Trial record 1 of 1 for:    GOG 0186J
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Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Persistent or Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01468909
First received: November 8, 2011
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

This randomized phase II trial is studying how well giving paclitaxel with or without pazopanib hydrochloride works in treating patients with persistent or recurrent ovarian epithelial, fallopian tube, or peritoneal cavity cancer. 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. Pazopanib hydrochloride may stop the growth of tumor cells by blocking blood flow to the tumor or by blocking some of the enzymes needed for cell growth. It is not yet known whether paclitaxel is more effective when given with or without pazopanib hydrochloride in treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.


Condition Intervention Phase
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Drug: pazopanib hydrochloride
Other: placebo
Drug: paclitaxel
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Phase IIB Evaluation of Weekly Paclitaxel (NSC #673089) Plus Pazopanib (NSC #737754) Versus Weekly Paclitaxel Plus Placebo in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Efficacy of each treatment regimen [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Evaluated using the Cox proportional hazards and stratified by platinum-free interval, measurable disease status, and prior use of bevacizumab. Maximum likelihood estimate of the logarithm of the hazard ratio of Arm 2 to Arm 1 for disease progression or death (PFS endpoint) will be calculated.


Secondary Outcome Measures:
  • Adverse events as assessed by CTCAE [ 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.

  • Frequency and duration of tumor response by RECIST, including CA-125 status [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The effects of treatment on the proportion responding by RECIST and possibly by CA125 will be examined. An examination of response by CA125 (stratified by treatment) will also be conducted in those patients who have measurable disease to assess the level of agreement between the two methods of evaluation. The impact of additional, various prognostic factors or biological markers will be examined with exploratory analyses including log-rank tests with characterization with hazard ratio estimates.

  • Overall survival (OS) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Differences between measurable versus non-measurable disease status on OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios.


Estimated Enrollment: 110
Study Start Date: December 2011
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm I (paclitaxel and placebo)
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: placebo
Given PO
Other Name: PLCB
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (paclitaxel and pazopanib hydrochloride)
Patients receive paclitaxel as in arm I and pazopanib hydrochloride PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: pazopanib hydrochloride
Given PO
Other Names:
  • GW786034B
  • Votrient
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To estimate the progression-free survival hazard ratio of the combination of weekly paclitaxel and pazopanib (pazopanib hydrochloride) compared to weekly paclitaxel and placebo in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.

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 in Solid Tumors (RECIST), cancer antigen 125 (CA125) response, the overall survival (OS), and the duration of response in each arm.

TERTIARY OBJECTIVES:

I. To explore the association between plasma cytokines and angiogenic markers and progression-free and overall survival.

II. To explore the association between single-nucleotide polymorphisms (SNPs) and progression-free and overall survival.

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

ARM I: Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15 and placebo orally (PO) daily on days 1-28.

ARM II: Patients receive paclitaxel as in arm I and pazopanib hydrochloride PO daily on days 1-28.

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

After completion of study therapy, 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 in a patient is defined in this protocol as one who does not have measurable disease but has 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 Gynecology 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 who have received one prior regimen must have a GOG performance status of 0, 1, or 2
  • Patients who have received two or three prior regimens must have a GOG performance status of 0 or 1
  • Recovered from effects of recent surgery, radiotherapy, or chemotherapy
  • 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 registration
  • 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 registration; 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 registration
  • At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy, thoracotomy, video-assisted thorascopic surgery [VATS]); there is no restriction on minor procedures (e.g., minor: central venous access catheter placement, ureteral stent placement or exchange, paracentesis, thoracentesis)
  • 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 can have been given weekly or every 3 weeks; treatment with weekly paclitaxel for recurrent or persistent disease is NOT allowed
  • 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 platelet-derived growth factor (PDGF) pathways for management of recurrent or persistent disease
  • Patients are allowed to receive, but are not required to receive, poly (ADP-ribose) polymerase (PARP) inhibitors for management of primary or recurrent/persistent disease (either alone or in combination with cytotoxic chemotherapy); for the purposes of this study, PARP inhibitors will be considered "cytotoxic"; PARP inhibitors will NOT count as a prior regimen when given alone
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/µL
  • Platelets greater than or equal to 100,000/µL
  • Hemoglobin greater than or equal to 9 g/dL
  • Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 x upper limit of normal (ULN) (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin)
  • Partial thromboplastin time (PTT) less than or equal to 1.5 x ULN
  • Urine protein should be screened by urinalysis; If urine protein is 2+ or higher, 24-hour urine protein should be obtained and the level must be < 1000 mg (< 1.0 g/24 hours) for patient enrollment
  • Creatinine less than or equal to 1.5 x institutional ULN
  • Bilirubin less than or equal to 1.5 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN
  • Subjects who have BOTH bilirubin greater than ULN and AST/ALT greater than ULN are not eligible
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Patients must have normal baseline thyroid function tests (thyroid-stimulating hormone [TSH], T3, T4); a history of hypothyroidism and/or hyperthyroidism is allowed, as long as the patient has stable well-controlled thyroid function for a minimum of 2 months
  • 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; pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects
  • Patients must have signed an approved informed consent and authorization permitting the release of personal health information
  • Patients must be capable of taking and absorbing oral medications and be clear of the following:

    • Any lesion, whether induced by tumor, radiation, or other conditions, that makes it difficult to swallow tablets
    • Active peptic ulcer disease
    • Prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel
    • Malabsorption syndrome
  • Any concomitant medications that are associated with a risk of QTc prolongation and/or Torsades de Pointes should be discontinued or replaced with drugs that do not carry these risks, if possible
  • Patients with personal or family history of congenital long QTc syndrome are NOT eligible
  • Strong inhibitors of cytochrome P-450 system (CYP)3A4 are prohibited
  • Strong inducers of CYP3A4 are prohibited

Exclusion Criteria:

  • Patients who have had previous treatment with pazopanib; patients who have had 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 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; 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
  • Patients with clinically significant cardiovascular disease including any of the following:

    • Uncontrolled hypertension, defined as systolic greater than 140 mm Hg or diastolic greater than 90 mm Hg despite antihypertensive medications
    • Congenital long QT syndrome or baseline QTc greater than 480 milliseconds
    • 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
    • Patients who have received prior treatment with an anthracycline (including doxorubicin and/or liposomal doxorubicin) must have an echocardiogram assessment and are excluded if they have an ejection fraction less than 50%
    • CTCAE Grade 2 or greater peripheral vascular disease (at least brief [less than 24 hours] episodes of ischemia managed non-surgically and without permanent deficit)
    • History of cardiac angioplasty or stenting within 6 months prior to registration
    • History of coronary artery bypass graft surgery within 6 months prior to registration
    • Arterial thrombosis within 6 months prior to registration
  • Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to the first date of study treatment
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • 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, 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 including primary brain tumor or any brain metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib
  • Known human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy
  • Patients with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:

    • Active peptic ulcer disease
    • Known gastrointestinal intraluminal metastatic lesions (gastrointestinal serosa metastatic lesions are permitted)
    • Inflammatory bowel disease (e.g., ulcerative colitis, Crohn disease)
    • Patients with clinical symptoms or signs of gastrointestinal obstruction
    • Patients who require parenteral hydration and/or nutrition
  • Patients who are pregnant or nursing
  • History of hemoptysis in excess of 2.5 mL (½ teaspoon) within 8 weeks prior to first dose of pazopanib
  • Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468909

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36688
United States, Arizona
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States, 85012
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
Gynecologic Oncology Associates-Newport Beach
Newport Beach, California, United States, 92663
United States, Connecticut
University of Connecticut
Farmington, Connecticut, United States, 06030
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Hartford Hospital
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
Women's Cancer Associates
Saint Petersburg, Florida, United States, 33701
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Central Georgia Gynecologic Oncology
Macon, Georgia, United States, 31201
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Hawaii
Hawaii Minority Based CCOP
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Saint Vincent Oncology Center
Indianapolis, Indiana, United States, 46260
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Associates In Womens Health
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Maine
Maine Medical Center-Bramhall Campus
Portland, Maine, United States, 04102
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States, 49307
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Munson Medical Center
Traverse City, Michigan, United States, 49684
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Freeman Health System
Joplin, Missouri, United States, 64804
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
Women's Cancer Care Associates LLC
Albany, New York, United States, 12208
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Kettering Medical Center
Kettering, Ohio, United States, 45429
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Reading Hospital
West Reading, Pennsylvania, United States, 19611
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute/Greenville CCOP
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, United States, 76104
United States, Washington
PeaceHealth Medical Group PC
Bellingham, Washington, United States, 98226
Harrison Medical Center
Bremerton, Washington, United States, 98310
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States, 98310
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Skagit Valley Hospital Regional Cancer Care Center
Mount Vernon, Washington, United States, 98273
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States, 98370
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Group Health Cooperative-Seattle
Seattle, Washington, United States, 98112
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Northwest Hospital
Seattle, Washington, United States, 98133
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
University of Washington Medical Center
Seattle, Washington, United States, 98195
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Olympic Medical Cancer Care Center
Sequim, Washington, United States, 98384
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, United States, 99204
Saint Joseph Medical Center
Tacoma, Washington, United States, 98405
Tacoma General Hospital
Tacoma, Washington, United States, 98405
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
Sponsors and Collaborators
Investigators
Principal Investigator: Debra Richardson Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01468909     History of Changes
Other Study ID Numbers: NCI-2011-03635, NCI-2011-03635, CDR0000716028, GOG-0186J, GOG-0186J, U10CA027469
Study First Received: November 8, 2011
Last Updated: July 28, 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 July 28, 2014