Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

This study is currently recruiting participants.
Verified March 2014 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01716715
First received: October 23, 2012
Last updated: April 4, 2014
Last verified: March 2014
  Purpose

This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or paclitaxel is more effective at treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer.


Condition Intervention Phase
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Drug: cabozantinib-s-malate
Drug: paclitaxel
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of NCI Supplied Cabozantinib (NSC #761968) Versus Weekly Paclitaxel (NSC #673089) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • PFS [ Time Frame: The duration of time from study entry to time to progression or death, whichever occurs first, assessed up to 32 weeks ] [ Designated as safety issue: No ]
    The data will be examined by a one-sided log-rank test to assess equivalence of equal risks of progressing or dying. The level of significance to be used is 10%.


Secondary Outcome Measures:
  • Frequency of adverse events, defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, graded according to the National Cancer Institute (NCI) CTCAE version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
    Toxicities will be characterized by their frequency and severity. Differences in the level of toxicities by treatment regimen will be assessed by classifying them as severe or not severe and examining the relative proportion of severe toxicities.

  • Severity of adverse events, defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, graded according to the NCI CTCAE version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
    Toxicities will be characterized by their frequency and severity. Differences in the level of toxicities by treatment regimen will be assessed by classifying them as severe or not severe and examining the relative proportion of severe toxicities.

  • Response, assessed according to RECIST version 1.1 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Response, assessed according to CA125 criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    An examination of response by CA125 (stratified by treatment) will be conducted in those patients who have measurable disease to assess the level of agreement between the two methods of evaluation.

  • Overall survival [ Time Frame: The duration of time from study entry to time of death or the date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    Differences between measurable versus non-measurable disease status will be examined with plots of survival curves, estimates of quartiles and hazard ratios. Formal tests for differences will be carried out with a Cox model or log-rank test if appropriate.

  • PFS [ Time Frame: The duration of time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years ] [ Designated as safety issue: No ]
    Differences between measurable versus non-measurable disease status will be examined with plots of survival curves, estimates of quartiles and hazard ratios. Formal tests for differences will be carried out with a Cox model or log-rank test if appropriate.

  • Duration of response (complete response [CR] or partial response [PR]) by treatment [ Time Frame: From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • c-Met expression [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • c-MET copy number [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: November 2012
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (cabozantinib-s-malate)
Patients receive cabozantinib-s-malate PO QD on days 1-28.
Drug: cabozantinib-s-malate
Given PO
Other Names:
  • BMS-907351
  • Cometriq
  • XL184
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (paclitaxel)
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the activity of cabozantinib (cabozantinib-s-malate) relative to weekly paclitaxel in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer with a log-rank test assessing progression-free survival (PFS) at 3.68 months (approximately pre-cycle 5) and 7.36 months (approximately pre-cycle 9).

SECONDARY OBJECTIVES:

I. To determine the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE).

II. To estimate and compare the proportion of patients responding to therapy by Response Evaluation Criteria for Solid Tumors (RECIST), cancer antigen 125 (CA125) response, the overall survival (OS), and the duration of response in each arm.

TERTIARY OBJECTIVES:

I. To retrospectively correlate c-met proto-oncogene (MET) expression with overall outcome.

II. To retrospectively correlate c-MET copy number with overall outcome.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28.

ARM II: Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
  • Patients must have measurable disease or non-measurable (detectable) disease:

    • Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be greater than or equal to 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or greater than or equal to 20 mm when measured by chest x-ray; lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI
    • Non-measurable (detectable) disease is defined in this protocol as the absence of measurable disease but at least one of the following conditions:

      • Ascites and/or pleural effusion attributed to tumor
      • Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions
  • Patients with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III or rare tumor protocol for the same patient population; in addition, patients must not be eligible for the currently active phase II cytotoxic protocol in platinum resistant disease
  • Patients must have a GOG performance status of 0, 1, or 2
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy to baseline or CTCAE =< grade 1 toxicity from all prior therapies except alopecia and other non-clinically significant adverse events (AE's):

    • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
    • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to treatment
    • Any other prior therapy directed at the malignant tumor, including chemotherapy, biological/targeted (non-cytotoxic) agents and immunologic agents, must be discontinued at least three weeks prior to treatment
    • Chimeric or human or humanized monoclonal antibodies (including bevacizumab) or vascular endothelial growth factor (VEGF) receptor fusion proteins (including VEGF TRAP/aflibercept) must be discontinued for at least 12 weeks prior to treatment
    • Investigational agents must be discontinued for at least 28 days prior to treatment
    • Any prior radiation therapy must be discontinued at least four weeks prior to treatment
  • Prior therapy

    • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents (e.g., bevacizumab) or extended therapy administered after surgical or non-surgical assessment; if patients were treated with paclitaxel for their primary disease, this could have been given weekly or every 3 weeks
    • Patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease, with no more than 1 non-platinum, non-taxane regimen; treatment with weekly paclitaxel for recurrent or persistent disease is NOT allowed
    • Patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary treatment regimen
    • Patients must have NOT received any biologic/targeted (non-cytotoxic) therapy targeting the VEGF and/or MET pathways for management of recurrent or persistent disease
    • For the purposes of this study, poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors will be considered "cytotoxic"; patients are allowed to receive, but are not required to receive, PARP inhibitors for management of primary or recurrent/persistent disease (either alone or in combination with cytotoxic chemotherapy); PARP inhibitors will NOT count as a prior regimen when given alone
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Hemoglobin greater than or equal to 9 g/dL
  • Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.3 x institutional upper limit of normal (ULN)
  • Partial thromboplastin time (PTT) less than or equal to 1.3 x ULN
  • Creatinine less than or equal to 1.5 x ULN
  • Phosphorus, corrected calcium, magnesium and potassium greater than or equal to institutional lower limit of normal (LLN)
  • Urine protein creatinine (UPC) ratio must be < 1.0 gm; if UPC ratio >= 1, collection of 24-hour urine measurement of urine protein is recommended
  • Bilirubin less than or equal to 1.5 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Albumin greater than or equal to 2.8 g/dL
  • Lipase less than or equal to 2 x ULN
  • No radiologic or clinical evidence of pancreatitis
  • Patients must have a normal baseline thyroid stimulating hormone (TSH); a history of hypothyroidism and/or hyperthyroidism is allowed
  • Neuropathy (sensory and motor) less than or equal to grade 1
  • Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; sexually active subjects must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug, even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug; pregnant women are excluded from this study
  • Patients must have signed an approved informed consent and authorization permitting the release of personal health information
  • Patients must meet pre-entry requirements

Exclusion Criteria:

  • Patients who have had previous treatment with cabozantinib; patients who have received previous treatment with weekly paclitaxel for recurrent or persistent disease
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or thoracic cavity within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Uncontrolled hypertension, defined as systolic greater than 140 mm Hg or diastolic greater than 90 mm Hg despite antihypertensive medications
  • Myocardial infarction or unstable angina within 6 months prior to registration
  • New York Heart Association (NYHA) class II or greater congestive heart failure
  • History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or serious cardiac arrhythmia requiring medication; this does not include asymptomatic atrial fibrillation with controlled ventricular rate
  • Any history of congenital long QT syndrome
  • The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; note: if initial QTcF is found to be > 500 ms, two additional electrocardiogram (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
  • Patients with serious non-healing wound, ulcer, or bone fracture within 28 days before treatment
  • Patients with history of organ transplant
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving (in contact with, invading or encasing) major vessels
  • Patients who have experienced any of the following:

    • Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment
    • Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months before the first dose of study treatment
    • Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
  • Patients who have radiographic evidence of cavitating pulmonary lesion(s)
  • Patients who have tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before treatment
  • Gastrointestinal disorders, particularly those with potential risk of perforation or fistula formation including:

    • Any of the following within 28 days of registration

      • Intra-abdominal tumor/metastases invading GI mucosa
      • Active peptic ulcer disease
      • Inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis
      • Malabsorption syndrome
    • Any of the following within 6 months of registration

      • Abdominal fistula
      • Gastrointestinal perforation
      • Bowel obstruction or gastric outlet obstruction; note: patients requiring drainage gastrostomy (e.g., percutaneous endoscopic gastrostomy [PEG] tube) and/or parenteral hydration and/or nutrition are not eligible
      • Intraabdominal abscess; note: complete resolution of an intraabdominal abscess must be confirmed prior to registration even if the abscess occurred more than 6 months prior to registration
  • Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures which are not controlled with non-enzyme inducing anticonvulsants, any brain metastases and/or epidural disease, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of study treatment
  • The subject requires chronic concomitant treatment of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort)
  • Patients who are unable or unwilling to swallow tablets
  • Patients who are pregnant or nursing
  • The subject requires concomitant treatment, in therapeutic doses, with anti-coagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors or antiplatelet agents (i.e. clopidogrel); low dose aspirin (=< 81 mg/day) low-dose warfarin (=< 1 mg/day) and prophylactic low molecular weight heparin are permitted
  • Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications
  • Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications
  • Patients with concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716715

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama Mitchell Cancer Institute Recruiting
Mobile, Alabama, United States, 36688
Contact: Rodney P. Rocconi    251-445-9870    pfrancisco@usouthal.edu   
Principal Investigator: Rodney P. Rocconi         
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Active, not recruiting
Burbank, California, United States, 91505
John Muir Medical Center-Concord Campus Active, not recruiting
Concord, California, United States, 94520
University of Southern California/Norris Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Huyen Q. Pham    323-865-0451      
Principal Investigator: Huyen Q. Pham         
Los Angeles County-USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Huyen Q. Pham    323-865-0451      
Principal Investigator: Huyen Q. Pham         
Cedars-Sinai Medical Center Active, not recruiting
Los Angeles, California, United States, 90048
Gynecologic Oncology Associates-Newport Beach Active, not recruiting
Newport Beach, California, United States, 92663
United States, Connecticut
Hartford Hospital Active, not recruiting
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut Active, not recruiting
New Britain, Connecticut, United States, 06050
United States, Delaware
Beebe Medical Center Active, not recruiting
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital Active, not recruiting
Newark, Delaware, United States, 19718
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224-9980
Contact: Gerardo Colon-Otero    507-538-7623      
Principal Investigator: Gerardo Colon-Otero         
United States, Georgia
Northeast Georgia Medical Center Active, not recruiting
Gainesville, Georgia, United States, 30501
Saint Joseph's-Candler Health System Active, not recruiting
Savannah, Georgia, United States, 31405
United States, Hawaii
University of Hawaii Active, not recruiting
Honolulu, Hawaii, United States, 96813
United States, Illinois
Rush University Medical Center Active, not recruiting
Chicago, Illinois, United States, 60612
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Seiko D. Yamada    773-834-7424      
Principal Investigator: Seiko D. Yamada         
Northwestern University Active, not recruiting
Chicago, Illinois, United States, 60611
Decatur Memorial Hospital Active, not recruiting
Decatur, Illinois, United States, 62526
Sudarshan K Sharma MD Limted-Gynecologic Oncology Active, not recruiting
Hinsdale, Illinois, United States, 60521
Good Samaritan Regional Health Center Active, not recruiting
Mount Vernon, Illinois, United States, 62864
United States, Indiana
Indiana University Medical Center Active, not recruiting
Indianapolis, Indiana, United States, 46202
Saint Vincent Oncology Center Active, not recruiting
Indianapolis, Indiana, United States, 46260
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
Iowa Lutheran Hospital Active, not recruiting
Des Moines, Iowa, United States, 50316
Iowa Oncology Research Association CCOP Active, not recruiting
Des Moines, Iowa, United States, 50309
Iowa Methodist Medical Center Active, not recruiting
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines Active, not recruiting
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel Active, not recruiting
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines Active, not recruiting
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: David P. Bender    800-237-1225      
Principal Investigator: David P. Bender         
United States, Kansas
Cancer Center of Kansas - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Liberal Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Manhattan Recruiting
Manhattan, Kansas, United States, 66502
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - McPherson Recruiting
McPherson, Kansas, United States, 67460
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Main Office Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Wichita CCOP Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Wichita Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Associates In Womens Health Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
United States, Louisiana
Woman's Hospital Recruiting
Baton Rouge, Louisiana, United States, 70817
Contact: Giles Fort    225-215-1353    clinicalreserach@marybird.com   
Principal Investigator: Giles Fort         
United States, Maine
Maine Medical Center-Bramhall Campus Recruiting
Portland, Maine, United States, 04102
Contact: Christopher J. Darus    207-885-7565      
Principal Investigator: Christopher J. Darus         
Maine Medical Center- Scarborough Campus Recruiting
Scarborough, Maine, United States, 04074
Contact: Christopher J. Darus    207-885-7565      
Principal Investigator: Christopher J. Darus         
United States, Maryland
Union Hospital of Cecil County Terminated
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ursula A. Matulonis    866-790-4500      
Principal Investigator: Ursula A. Matulonis         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ursula A. Matulonis    866-790-4500      
Principal Investigator: Ursula A. Matulonis         
Baystate Medical Center Active, not recruiting
Springfield, Massachusetts, United States, 01199
University of Massachusetts Memorial Health Care Active, not recruiting
Worcester, Massachusetts, United States, 01605
United States, Michigan
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord    269-373-7458      
Principal Investigator: Raymond S. Lord         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord    269-373-7458      
Principal Investigator: Raymond S. Lord         
West Michigan Cancer Center Active, not recruiting
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Sanford Clinic North-Bemidgi Recruiting
Bemidji, Minnesota, United States, 56601
Contact: Maria C. Bell    218-333-5000      
Principal Investigator: Maria C. Bell         
United States, Mississippi
Saint Dominic-Jackson Memorial Hospital Active, not recruiting
Jackson, Mississippi, United States, 39216
University of Mississippi Medical Center Active, not recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
Saint Francis Medical Center Active, not recruiting
Cape Girardeau, Missouri, United States, 63703
Freeman Health System Active, not recruiting
Joplin, Missouri, United States, 64804
Saint John's Mercy Medical Center Active, not recruiting
Saint Louis, Missouri, United States, 63141
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: David G. Mutch    800-600-3606    info@ccadmin.wustl.edu   
Principal Investigator: David G. Mutch         
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Active, not recruiting
Springfield, Missouri, United States, 65802
CoxHealth South Hospital Active, not recruiting
Springfield, Missouri, United States, 65807
Mercy Hospital Springfield Active, not recruiting
Springfield, Missouri, United States, 65804
United States, Nebraska
Nebraska Methodist Hospital Active, not recruiting
Omaha, Nebraska, United States, 68114
United States, Nevada
Women's Cancer Center of Nevada Active, not recruiting
Las Vegas, Nevada, United States, 89169
United States, New Hampshire
Dartmouth Hitchcock Medical Center Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New York
Winthrop University Hospital Active, not recruiting
Mineola, New York, United States, 11501
New York University Langone Medical Center Active, not recruiting
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Vicky Makker    212-639-7202      
Principal Investigator: Vicky Makker         
Stony Brook University Medical Center Active, not recruiting
Stony Brook, New York, United States, 11794
United States, North Carolina
University of North Carolina Active, not recruiting
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Robert V. Higgins    704-355-2884      
Principal Investigator: Robert V. Higgins         
New Hanover Regional Medical Center Active, not recruiting
Wilmington, North Carolina, United States, 28401
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Samuel S. Lentz    336-713-6771      
Principal Investigator: Samuel S. Lentz         
United States, North Dakota
Sanford Bismarck Medical Center Active, not recruiting
Bismarck, North Dakota, United States, 58501
Sanford Clinic North-Fargo Recruiting
Fargo, North Dakota, United States, 58122
Contact: Maria C. Bell    218-333-5000      
Principal Investigator: Maria C. Bell         
Roger Maris Cancer Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Maria C. Bell    218-333-5000      
Principal Investigator: Maria C. Bell         
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center Recruiting
Akron, Ohio, United States, 44304
Contact: Vivian E. von Gruenigen    330-375-6101      
Principal Investigator: Vivian E. von Gruenigen         
Case Western Reserve University Active, not recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation Active, not recruiting
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center/Fairview Hospital Active, not recruiting
Cleveland, Ohio, United States, 44111
Riverside Methodist Hospital Active, not recruiting
Columbus, Ohio, United States, 43214
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Christopher V. Lutman    937-208-2387      
Principal Investigator: Christopher V. Lutman         
Hillcrest Hospital Cancer Center Active, not recruiting
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center Active, not recruiting
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
Tulsa Cancer Institute Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Robert S. Mannel    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Parviz Hanjani    215-481-2402      
Principal Investigator: Parviz Hanjani         
United States, Rhode Island
Women and Infants Hospital Active, not recruiting
Providence, Rhode Island, United States, 02905
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Maria C. Bell    218-333-5000      
Principal Investigator: Maria C. Bell         
Sanford Cancer Center-Oncology Clinic Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Maria C. Bell    218-333-5000      
Principal Investigator: Maria C. Bell         
United States, Texas
The Don and Sybil Harrington Cancer Center Active, not recruiting
Amarillo, Texas, United States, 79106
Baylor All Saints Medical Center at Fort Worth Active, not recruiting
Fort Worth, Texas, United States, 76104
Lyndon Baines Johnson General Hospital Active, not recruiting
Houston, Texas, United States, 77026-1967
M D Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lois M. Ramondetta       lramonde@mdanderson.org   
Principal Investigator: Lois M. Ramondetta         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Susan C. Modesitt    434-243-6143      
Principal Investigator: Susan C. Modesitt         
Virginia Commonwealth University Active, not recruiting
Richmond, Virginia, United States, 23298
United States, Washington
PeaceHealth Medical Group PC Recruiting
Bellingham, Washington, United States, 98226
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Harrison Medical Center Recruiting
Bremerton, Washington, United States, 98310
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Harrison HealthPartners Hematology and Oncology-Bremerton Recruiting
Bremerton, Washington, United States, 98310
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Providence Regional Cancer Partnership Recruiting
Everett, Washington, United States, 98201
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Skagit Valley Hospital Regional Cancer Care Center Recruiting
Mount Vernon, Washington, United States, 98273
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Harrison HealthPartners Hematology and Oncology-Poulsbo Recruiting
Poulsbo, Washington, United States, 98370
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Northwest Hospital Recruiting
Seattle, Washington, United States, 98133
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Pacific Gynecology Specialists Recruiting
Seattle, Washington, United States, 98104
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Group Health Cooperative-Seattle Recruiting
Seattle, Washington, United States, 98112
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Swedish Medical Center-First Hill Recruiting
Seattle, Washington, United States, 98122-4307
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Olympic Medical Cancer Care Center Recruiting
Sequim, Washington, United States, 98384
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Cancer Care Northwest - Spokane South Recruiting
Spokane, Washington, United States, 99202
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Rockwood Cancer Treatment Center-Downtown Recruiting
Spokane, Washington, United States, 99204
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Saint Joseph Medical Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Tacoma General Hospital Terminated
Tacoma, Washington, United States, 98405
Providence Saint Mary Regional Cancer Center Recruiting
Walla Walla, Washington, United States, 99362
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
Wenatchee Valley Medical Center Recruiting
Wenatchee, Washington, United States, 98801
Contact: Benjamin E. Greer    206-616-8289      
Principal Investigator: Benjamin E. Greer         
United States, Wisconsin
Sacred Heart Hospital Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Anthony C. Evans    715-389-4457      
Principal Investigator: Anthony C. Evans         
Marshfield Clinic Cancer Center at Sacred Heart Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Anthony C. Evans    715-389-4457      
Principal Investigator: Anthony C. Evans         
University of Wisconsin Hospital and Clinics Active, not recruiting
Madison, Wisconsin, United States, 53792
Saint Joseph's Hospital Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Anthony C. Evans    715-389-4457      
Principal Investigator: Anthony C. Evans         
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Anthony C. Evans    715-389-4457      
Principal Investigator: Anthony C. Evans         
Marshfield Clinic-Minocqua Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Anthony C. Evans    715-389-4457      
Principal Investigator: Anthony C. Evans         
Marshfield Clinic at James Beck Cancer Center Recruiting
Rhinelander, Wisconsin, United States, 54501
Contact: Anthony C. Evans    715-389-4457      
Principal Investigator: Anthony C. Evans         
Marshfield Clinic-Rice Lake Center Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Anthony C. Evans    715-389-4457      
Principal Investigator: Anthony C. Evans         
Marshfield Clinic Cancer Care at Saint Michael's Hospital Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Anthony C. Evans    715-389-4457      
Principal Investigator: Anthony C. Evans         
Saint Michael's Hospital Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Anthony C. Evans    715-389-4457      
Principal Investigator: Anthony C. Evans         
Waukesha Memorial Hospital - ProHealth Care Active, not recruiting
Waukesha, Wisconsin, United States, 53188
Diagnostic and Treatment Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Anthony C. Evans    715-389-4457      
Principal Investigator: Anthony C. Evans         
Marshfield Clinic - Weston Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Anthony C. Evans    715-389-4457      
Principal Investigator: Anthony C. Evans         
Marshfield Clinic - Wisconsin Rapids Center Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Anthony C. Evans    715-389-4457      
Principal Investigator: Anthony C. Evans         
Sponsors and Collaborators
Investigators
Principal Investigator: Ursula Matulonis Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01716715     History of Changes
Other Study ID Numbers: NCI-2012-02058, NCI-2012-02058, GOG-0186K, GOG-0186K, U10CA027469
Study First Received: October 23, 2012
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014