Trial record 1 of 2 for:    GOG 0268
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Temsirolimus, Carboplatin, and Paclitaxel as First-Line Therapy in Treating Patients With Newly Diagnosed Stage III-IV Clear Cell Ovarian Cancer

This study is currently recruiting participants.
Verified December 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01196429
First received: September 4, 2010
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

This phase II trial studies how well temsirolimus, carboplatin, and paclitaxel as first-line therapy works in treating patients with newly diagnosed stage III-IV clear cell ovarian cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus with combination chemotherapy may be an effective treatment for ovarian cancer.


Condition Intervention Phase
Ovarian Clear Cell Cystadenocarcinoma
Stage III Ovarian Epithelial Cancer
Stage IV Ovarian Epithelial Cancer
Drug: paclitaxel
Drug: carboplatin
Drug: temsirolimus
Drug: docetaxel
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Temsirolimus (CCI-779) (NCI Supplied Agent: NSC# 683864, IND# 61010) in Combination With Carboplatin and Paclitaxel Followed by Temsirolimus (CCI-779) Consolidation as First-Line Therapy in the Treatment of Stage III-IV Clear Cell Carcinoma of the Ovary

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of patients who survive progression-free for at least 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Will be characterized with Kaplan-Meier plots.


Secondary Outcome Measures:
  • Incidence of adverse events as assessed by CTCAE v4, reported by frequency and severity [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    The frequency and severity of all toxicities will be tabulated.

  • Duration of progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be characterized with Kaplan-Meier plots.

  • Duration of overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be characterized with Kaplan-Meier plots.

  • Proportion of patients who have objective tumor response (complete or partial) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • IHC expression of components of the mTOR signaling pathway [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: August 2010
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (paclitaxel, carboplatin, temsirolimus, docetaxel)

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and temsirolimus IV on days 1 and 8. Treatment repeats every 3 weeks for 6 courses. Patients then receive consolidation therapy comprising temsirolimus IV on days 1, 8, and 15. Treatment repeats every 3 weeks for 11 courses in the absence of disease progression or unacceptable toxicity.

NOTE: * For circumstances in which docetaxel should be substituted for paclitaxel, docetaxel is given IV over 1 hour.

Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: temsirolimus
Given IV
Other Names:
  • CCI-779
  • cell cycle inhibitor 779
  • Torisel
Drug: docetaxel
Given IV
Other Names:
  • RP 56976
  • Taxotere
  • TXT
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the activity of the study regimen as measured by the proportion of patients who are alive and progression-free for at least 12 months after study entry in patients with newly diagnosed stage III or IV clear cell ovarian cancer in the following populations: patients in the United States (U.S.) and worldwide (outside of Japan) and patients in Japan.

II. To compare progression-free survival in newly diagnosed stage III or IV clear cell ovarian cancer patients in patients in the U.S. and worldwide (outside of Japan) versus patients in Japan.

SECONDARY OBJECTIVES:

I. To characterize the duration of overall survival and progression-free survival in each population.

II. To examine the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4 in each population.

III. To estimate the rate of objective tumor response in patients with measurable disease.

TERTIARY OBJECTIVES:

I. To explore whether immunohistochemical (IHC) expression of components of the mammalian target of rapamycin (mTOR) signaling pathway (phosphatase and tensin homolog [PTEN], total and phosphorylated protein kinase B [Akt], as well as, ATP-binding cassette, sub-family C [CFTR/MRP], member 3 [ABCC3] [MRP3], ATPase, H+ transporting, lysosomal accessory protein 1 [AB CF2], cyclin E, and vascular endothelial growth factor [VEGF]) are associated with outcome, nationality or clinical characteristics.

II. To explore whether there is any differences in differential gene expression profiles between U.S. and worldwide (outside of Japan) versus Japanese patients.

OUTLINE:

Patients receive paclitaxel* intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1 and temsirolimus IV on days 1 and 8. Treatment repeats every 3 weeks for 6 courses. Patients then receive consolidation therapy comprising temsirolimus IV on days 1, 8, and 15. Treatment repeats every 3 weeks for 11 courses in the absence of disease progression or unacceptable toxicity.

NOTE: * For circumstances in which docetaxel should be substituted for paclitaxel, docetaxel is given IV over 1 hour.

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 stage III or IV clear cell ovarian cancer; primary tumors must be at least 50% clear cell histomorphology in order to be eligible; in addition, the tumors should be negative for expression of Wilms tumor 1 (WT-1) antigen and estrogen receptor (ER) antigen by immunohistochemistry; appropriate tissue sections to confirm stage and histologic classification of cell type must be sent to Gynecologic Oncology Group (GOG) for central pathology review; immunohistochemical stained slides for ER and WT-1 antigen must be also be submitted to GOG for pathology review
  • Patients who have met the pre-entry requirements
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients with a GOG performance status of 0, 1, or 2
  • Patients must be entered between 2 and 12 weeks after initial surgery; performed for the combined purpose of diagnosis, staging and cytoreduction
  • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
  • Absolute neutrophil count >= 1,500/mcl
  • Platelets >= 100,000/mcl
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 times institutional upper limit of normal (< 5 times upper limit of normal [ULN] for subjects with liver metastases)
  • Alkaline phosphatase =< 2.5 times institutional upper limit of normal (< 5 times ULN for subjects with liver metastases)
  • Creatinine =< 1.5 x institutional upper limit of normal, grade 1 per CTCAE v. 4.0
  • Cholesterol =< 350 mg/dL (fasting)
  • Triglycerides =< 400 mg/dL (fasting)
  • Albumin >= 3.0 g/dL
  • Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thrombo-embolus)
  • Partial thromboplastin time (PTT) < 1.2 times the upper limit of normal
  • Neurologic function (sensory and motor) =< CTCAE grade 1

Exclusion Criteria:

  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five 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 are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than five 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 including neo-adjuvant chemotherapy for their clear cell ovarian cancer
  • Patients with primary peritoneal and fallopian tube carcinoma are not eligible
  • Previous treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus), paclitaxel, or carboplatin
  • Patients cannot be receiving enzyme-inducing antiepileptic drugs (enzyme-inducing antiepileptic drugs [EIAEDs]; e.g., phenytoin, carbamazepine, phenobarbital) nor any other cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer such as rifampin or St. John's Wort; use of agents that potently inhibit CYP3A4 (and hence may raise temsirolimus levels), such as ketoconazole, is discouraged, but not specifically prohibited; the appropriateness of use of such agents is left to physician discretion; strong CYP3A4 inhibitors are prohibited
  • Patients receiving any investigational agents
  • Patients with severely impaired lung function defined as a diffusion lung capacity for carbon monoxide (DLCO) =< 50% of the normal predicted value and/or oxygen (O2) saturation =< 88% at rest on room air
  • Patients with symptomatic congestive heart failure of New York Heart Association class III or IV, unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant disease
  • 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 on maintenance corticosteroids are ineligible with the exception of short term use (fewer than 5 days)
  • Patients with baseline requirement for oxygen
  • Patients with serious concomitant illness which, in the opinion of the treating physician, will place patient at unreasonable risk from therapy on this protocol
  • Patients who are pregnant or nursing; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of study therapies
  • Patients with poorly controlled diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196429

  Hide Study Locations
Locations
United States, Arizona
Saint Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: John H. Farley    877-602-4111      
Principal Investigator: John H. Farley         
United States, California
Providence Saint Joseph Medical Center Recruiting
Burbank, California, United States, 91505
Contact: Richard L. Friedman    818-847-3220      
Principal Investigator: Richard L. Friedman         
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         
University of Southern California Recruiting
Los Angeles, California, United States, 90033-0804
Contact: Huyen Q. Pham    323-865-0451      
Principal Investigator: Huyen Q. Pham         
Palo Alto Medical Foundation-Gynecologic Oncology Recruiting
Mountain View, California, United States, 94040
Contact: Albert L. Pisani    650-934-7000      
Principal Investigator: Albert L. Pisani         
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Susan A. Davidson    720-848-0650      
Principal Investigator: Susan A. Davidson         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Amy K. Brown    860-545-5363      
Principal Investigator: Amy K. Brown         
Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
The Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States, 06050
Contact: James S. Hoffman    860-224-5660      
Principal Investigator: James S. Hoffman         
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: James E. Kendrick    407-303-5623      
Principal Investigator: James E. Kendrick         
United States, Georgia
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403
Contact: James J. Burke    912-350-8568      
Principal Investigator: James J. Burke         
United States, Idaho
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Emily Berry    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Emily Berry         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Jacob Rotmensch    312-942-5498    clinical_trials@rush.edu   
Principal Investigator: Jacob Rotmensch         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Seiko D. Yamada    773-834-7424      
Principal Investigator: Seiko D. Yamada         
Sudarshan K Sharma MD Limted-Gynecologic Oncology Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Sudarshan K. Sharma    630-856-6757      
Principal Investigator: Sudarshan K. Sharma         
Good Samaritan Regional Medical Center Recruiting
Mt. Vernon, Illinois, United States, 62864
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Central DuPage Hospital Cancer Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: Barbara M. Buttin    630-352-5300    cancer@northwestern.edu   
Principal Investigator: Barbara M. Buttin         
United States, Indiana
Elkhart Clinic Recruiting
Elkhart, Indiana, United States, 46514-2098
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
Michiana Hematology Oncology PC-Elkhart Recruiting
Elkhart, Indiana, United States, 46514
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
Indiana University Medical Center Active, not recruiting
Indianapolis, Indiana, United States, 46202
Saint Vincent Oncology Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Gregory P. Sutton    317-338-2194      
Principal Investigator: Gregory P. Sutton         
Community Howard Regional Health Recruiting
Kokomo, Indiana, United States, 46904
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
Indiana University Health La Porte Hospital Recruiting
La Porte, Indiana, United States, 46350
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
Michiana Hematology Oncology PC-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
Saint Joseph Regional Medical Center-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
Michiana Hematology Oncology PC-Plymouth Recruiting
Plymouth, Indiana, United States, 46563
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
Michiana Hematology Oncology PC-South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
Northern Indiana Cancer Research Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
South Bend Clinic Recruiting
South Bend, Indiana, United States, 46617
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
Michiana Hematology Oncology-PC Westville Recruiting
Westville, Indiana, United States, 46391
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
United States, Iowa
Iowa Lutheran Hospital Recruiting
Des Moines, Iowa, United States, 50316
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Iowa Oncology Research Association CCOP Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Medical Oncology and Hematology Associates-Des Moines Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Medical Oncology and Hematology Associates Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Julia A. Chapman    913-588-4709      
Principal Investigator: Julia A. Chapman         
United States, Maryland
Walter Reed Army Medical Center-Olney Recruiting
Olney, Maryland, United States, 20832
Contact: Sarah Bernstein    202-782-3559    sarah.bernstein@med.navy.mil   
Principal Investigator: Sarah Bernstein         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Michael J. Birrer    617-726-8624    mbirrer@partners.org   
Principal Investigator: Michael J. Birrer         
Lahey Hospital and Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Corrine L. Zarwan    781-744-8027      
Principal Investigator: Corrine L. Zarwan         
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Tashanna K. Myers    413-794-3565    tamara.wrenn@baystatehealth.org   
Principal Investigator: Tashanna K. Myers         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Michigan Cancer Research Consortium Community Clinical Oncology Program Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Oakwood Hospital Recruiting
Dearborn, Michigan, United States, 48124
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Robert T. Morris    313-576-9363      
Principal Investigator: Robert T. Morris         
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48502
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Genesys Regional Medical Center Active, not recruiting
Grand Blanc, Michigan, United States, 48439
Gynecologic Oncology of West Michigan PLLC Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Gordon O. Downey    616-957-3398      
Principal Investigator: Gordon O. Downey         
Allegiance Health Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
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 Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord    269-373-7458      
Principal Investigator: Raymond S. Lord         
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord    269-373-7458      
Principal Investigator: Raymond S. Lord         
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Michiana Hematology Oncology PC-Niles Terminated
Niles, Michigan, United States, 49120
Saint Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint Joseph Mercy Port Huron Recruiting
Port Huron, Michigan, United States, 48060
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint Mary's of Michigan Recruiting
Saginaw, Michigan, United States, 48601
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Marie Yeager Cancer Center Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
Lakeland Hospital Recruiting
St. Joseph, Michigan, United States, 49085
Contact: Michael Rodriguez    574-237-1328      
Principal Investigator: Michael Rodriguez         
Saint John Macomb-Oakland Hospital Terminated
Warren, Michigan, United States, 48093
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: James T. Thigpen    601-815-6700      
Principal Investigator: James T. Thigpen         
United States, Missouri
Saint John's Regional Medical Center Recruiting
Joplin, Missouri, United States, 64804
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Recruiting
Springfield, Missouri, United States, 65802
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Saint John's Hospital Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Cox Medical Center Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Contact: Peter C. Morris    402-354-7939    kathryn.bartz@nmhs.org   
Principal Investigator: Peter C. Morris         
United States, Nevada
Women's Cancer Center of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Nicola M. Spirtos    702-851-4672      
Principal Investigator: Nicola M. Spirtos         
United States, New Jersey
Cooper Hospital University Medical Center Recruiting
Camden, New Jersey, United States, 08103
Contact: David P. Warshal    856-325-6757      
Principal Investigator: David P. Warshal         
United States, New York
Winthrop University Hospital Active, not recruiting
Mineola, New York, United States, 11501
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Michael L. Pearl    800-862-2215      
Principal Investigator: Michael L. Pearl         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Linda Van Le    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Linda Van Le         
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Robert V. Higgins    704-355-2884      
Principal Investigator: Robert V. Higgins         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Angeles A. Secord    888-275-3853      
Principal Investigator: Angeles A. Secord         
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, Ohio
Summa Akron City Hospital Recruiting
Akron, Ohio, United States, 44304
Contact: Vivian E. von Gruenigen    330-375-6101      
Principal Investigator: Vivian E. von Gruenigen         
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Eric L. Eisenhauer    513-558-4553    uchealthnews@uc.edu   
Principal Investigator: Eric L. Eisenhauer         
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Cleveland Clinic Cancer Center/Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: David M. O'Malley    866-627-7616    osu@emergingmed.com   
Principal Investigator: David M. O'Malley         
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Contact: Thomas J. Reid    937-298-3399    uchealthnews@uc.edu   
Principal Investigator: Thomas J. Reid         
Hillcrest Hospital Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Lake University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
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         
Cancer Care Associates-Yale Recruiting
Tulsa, Oklahoma, United States, 74136-1929
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         
Geisinger Medical Center Active, not recruiting
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Center-Cancer Center Hazelton Active, not recruiting
Hazleton, Pennsylvania, United States, 18201
Geisinger Medical Group Active, not recruiting
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley Active, not recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Rhode Island
Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Paul A. DiSilvestro    401-274-1122      
Principal Investigator: Paul A. DiSilvestro         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jubilee Brown       jbbrown@mdanderson.org   
Principal Investigator: Jubilee Brown         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jubilee Brown    713-792-3245      
Principal Investigator: Jubilee Brown         
United States, Utah
McKay-Dee Hospital Center Withdrawn
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center Withdrawn
Provo, Utah, United States, 84604-3337
Dixie Medical Center Regional Cancer Center Withdrawn
Saint George, Utah, United States, 84770
LDS Hospital Withdrawn
Salt Lake City, Utah, United States, 84143
United States, Washington
PeaceHealth Medical Group PC Active, not recruiting
Bellingham, Washington, United States, 98226
Harrison Bremerton Hematology and Oncology Active, not recruiting
Bremerton, Washington, United States, 98310
Harrison Medical Center Active, not recruiting
Bremerton, Washington, United States, 98310
Providence Regional Cancer Partnership Active, not recruiting
Everett, Washington, United States, 98201
Skagit Valley Hospital Regional Cancer Care Center Active, not recruiting
Mount Vernon, Washington, United States, 98274
Harrison Poulsbo Hematology and Oncology Active, not recruiting
Poulsbo, Washington, United States, 98370
Northwest Hospital Active, not recruiting
Seattle, Washington, United States, 98133
Group Health Cooperative Active, not recruiting
Seattle, Washington, United States, 98112
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Active, not recruiting
Seattle, Washington, United States, 98109
Pacific Gynecology Specialists Active, not recruiting
Seattle, Washington, United States, 98104
University of Washington Medical Center Active, not recruiting
Seattle, Washington, United States, 98195
Swedish Medical Center-First Hill Active, not recruiting
Seattle, Washington, United States, 98122-4307
Seattle Cancer Care Alliance Active, not recruiting
Seattle, Washington, United States, 98109-1023
Olympic Medical Cancer Care Center Active, not recruiting
Sequim, Washington, United States, 98384
Rockwood Cancer Treatment Center Active, not recruiting
Spokane, Washington, United States, 99204
Cancer Care Northwest - Spokane South Active, not recruiting
Spokane, Washington, United States, 99202
Tacoma General Hospital Active, not recruiting
Tacoma, Washington, United States, 98405
Saint Joseph Medical Center Active, not recruiting
Tacoma, Washington, United States, 98405
Providence Saint Mary Regional Cancer Center Active, not recruiting
Walla Walla, Washington, United States, 99362
Wenatchee Valley Medical Center Active, not recruiting
Wenatchee, Washington, United States, 98801
United States, Wisconsin
University of Wisconsin Hospital and Clinics Enrolling by invitation
Madison, Wisconsin, United States, 53792
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: William H. Bradley    414-805-4380      
Principal Investigator: William H. Bradley         
Japan
Tohoku University School of Medicine Recruiting
Sendai, Aoba-ku, Japan, 980-8574
Contact: Nobuo Yaegashi       med-som@bureau.tohoku.ac.jp   
Principal Investigator: Nobuo Yaegashi         
Kure National Hospital Recruiting
Kure, Hiroshima, Japan, 737
Contact: Kazuhiro Takehara    089-999-1172      
Principal Investigator: Kazuhiro Takehara         
Hokkaido University Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Contact: Noriaki Sakuragi       hassi@med.hokudai.ac.jp   
Principal Investigator: Noriaki Sakuragi         
Hyogo Cancer Center Recruiting
Akashi-city, Hyogo, Japan, 673-8558
Contact: Kiyoshi Fujiwara    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Kiyoshi Fujiwara         
Iwate Medical University School of Medicine Recruiting
Morioka, Iwate, Japan, 020-8505
Contact: Toru Sugiyama    019-651-5111      
Principal Investigator: Toru Sugiyama         
University of the Ryukyus Hospital-Col Health Scnc Recruiting
Nakagami-gun, Okinawa, Japan, 903-0215
Contact: Yoichi Aoki       sgriffin@gog.org   
Principal Investigator: Yoichi Aoki         
Shizuoka Cancer Center Recruiting
Shizuoka City, Suntou, Japan, 411-8777
Contact: Munetaka Takekuma       sgriffin@gog.org   
Principal Investigator: Munetaka Takekuma         
Keio University Recruiting
Shinjuku-ku, Tokyo, Japan, 160-8582
Contact: Daisuke Aoki    03 5363-3848      
Principal Investigator: Daisuke Aoki         
Kagoshima City Hospital Recruiting
Kagoshima City, Kagoshima, Japan, 892-8580
Contact: Masayuki Hatae    011 81 099 224 2101      
Principal Investigator: Masayuki Hatae         
Shikoku Cancer Center Active, not recruiting
Matsuyama, Japan, 791-0280
National Kyushu Cancer Center Recruiting
Minami-ku, Japan, 811 1395
Contact: Toshiaki Saito    092-641-1151      
Principal Investigator: Toshiaki Saito         
Jikei University School of Medicine Recruiting
Minato-ku, Tokyo, Japan, 105-8461
Contact: Kyosuke Yamada    03-3433-1111 ext 2153      
Principal Investigator: Kyosuke Yamada         
Kinki University Recruiting
Osaka, Osaka, Japan, 589 8511
Contact: Yoh Watanabe    072-366-0221    med-som@bureau.tohoku.ac.jp   
Principal Investigator: Yoh Watanabe         
Saitama Medical University International Medical Center Recruiting
Saitama, Japan, 350-1298
Contact: Keiichi Fujiwara    81-49-276-2028      
Principal Investigator: Keiichi Fujiwara         
National Cancer Center Hospital Recruiting
Tokyo, Japan, 104 0045
Contact: Mayu Yunokawa    81-3-3542-2511    www-admin@ncc.go.jp   
Principal Investigator: Mayu Yunokawa         
Tottori University Recruiting
Tottori, Japan, 680-8550
Contact: Junzo Kigawa    0857-31-5007      
Principal Investigator: Junzo Kigawa         
Korea, Republic of
Keimyung University-Dongsan Medical Center Active, not recruiting
Jung-Ku, Daegu, Korea, Republic of, 700-712
National Cancer Center-Korea Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Sang Y. Park    011-82-760-2384      
Principal Investigator: Sang Y. Park         
Samsung Medical Center Recruiting
Seoul, Korea, Korea, Republic of, 135-710
Contact: Duk-Soo Bae    011-82-1599-3114      
Principal Investigator: Duk-Soo Bae         
Korea Cancer Center Hospital Active, not recruiting
Seoul, Korea, Republic of, 139-706
Gangnam Severance Hospital Active, not recruiting
Seoul, Korea, Republic of, 120-752
Asan Medical Center Active, not recruiting
Seoul, Korea, Republic of, 138-736
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jae W. Kim    011-82-760-2384      
Principal Investigator: Jae W. Kim         
Sponsors and Collaborators
Investigators
Principal Investigator: John Farley Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01196429     History of Changes
Other Study ID Numbers: NCI-2011-02653, NCI-2011-02653, CDR0000684262, GOG-0268, GOG-0268, U10CA027469
Study First Received: September 4, 2010
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystadenocarcinoma
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Sirolimus
Everolimus
Docetaxel
Carboplatin
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014