Trial record 1 of 1 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. (see Contacts and Locations)
Verified June 2014 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: September 2, 2014
Last verified: June 2014
  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,) 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
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: NCT01196429

  Hide Study Locations
Locations
United States, Arizona
Saint Joseph's Hospital and Medical Center Completed
Phoenix, Arizona, United States, 85013
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Completed
Burbank, California, United States, 91505
Los Angeles County-USC Medical Center Completed
Los Angeles, California, United States, 90033
University of Southern California/Norris Cancer Center Completed
Los Angeles, California, United States, 90033
Palo Alto Medical Foundation-Gynecologic Oncology Completed
Mountain View, California, United States, 94040
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Completed
Aurora, Colorado, United States, 80045
United States, Connecticut
Hartford Hospital Completed
Hartford, Connecticut, United States, 06102
Saint Francis Hospital and Medical Center Completed
Hartford, Connecticut, United States, 06105
The Hospital of Central Connecticut Completed
New Britain, Connecticut, United States, 06050
United States, Florida
Florida Hospital Completed
Orlando, Florida, United States, 32803
United States, Georgia
Memorial University Medical Center Completed
Savannah, Georgia, United States, 31404
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Completed
Boise, Idaho, United States, 83706
United States, Illinois
Northwestern University Completed
Chicago, Illinois, United States, 60611
University of Chicago Completed
Chicago, Illinois, United States, 60637
Rush University Medical Center Completed
Chicago, Illinois, United States, 60612
Sudarshan K Sharma MD Limted-Gynecologic Oncology Completed
Hinsdale, Illinois, United States, 60521
Good Samaritan Regional Health Center Completed
Mount Vernon, Illinois, United States, 62864
Cadence Cancer Center in Warrenville Completed
Warrenville, Illinois, United States, 60555
United States, Indiana
Elkhart Clinic Completed
Elkhart, Indiana, United States, 46514-2098
Michiana Hematology Oncology PC-Elkhart Completed
Elkhart, Indiana, United States, 46514
Elkhart General Hospital Completed
Elkhart, Indiana, United States, 46515
Indiana University Medical Center Completed
Indianapolis, Indiana, United States, 46202
Saint Vincent Oncology Center Completed
Indianapolis, Indiana, United States, 46260
Community Howard Regional Health Completed
Kokomo, Indiana, United States, 46904
IU Health La Porte Hospital Completed
La Porte, Indiana, United States, 46350
Michiana Hematology Oncology PC-Mishawaka Completed
Mishawaka, Indiana, United States, 46545-1470
Saint Joseph Regional Medical Center-Mishawaka Completed
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Plymouth Completed
Plymouth, Indiana, United States, 46563
South Bend Clinic Completed
South Bend, Indiana, United States, 46617
Memorial Hospital of South Bend Completed
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-South Bend Completed
South Bend, Indiana, United States, 46601
Northern Indiana Cancer Research Consortium Completed
South Bend, Indiana, United States, 46628
Michiana Hematology Oncology-PC Westville Completed
Westville, Indiana, United States, 46391
United States, Iowa
Iowa Lutheran Hospital Completed
Des Moines, Iowa, United States, 50316
Iowa Methodist Medical Center Completed
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP Completed
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines Completed
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel Completed
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines Completed
Des Moines, Iowa, United States, 50314
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 Completed
Burlington, Massachusetts, United States, 01805
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 Completed
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program Completed
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital and Medical Center Completed
Dearborn, Michigan, United States, 48124
Wayne State University/Karmanos Cancer Institute Completed
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center Completed
Detroit, Michigan, United States, 48236
Hurley Medical Center Completed
Flint, Michigan, United States, 48502
Genesys Regional Medical Center Completed
Grand Blanc, Michigan, United States, 48439
Gynecologic Oncology of West Michigan PLLC Completed
Grand Rapids, Michigan, United States, 49546
Allegiance Health Completed
Jackson, Michigan, United States, 49201
Bronson Methodist Hospital Completed
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center Completed
Kalamazoo, Michigan, United States, 49001
West Michigan Cancer Center Completed
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital Completed
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital Completed
Livonia, Michigan, United States, 48154
Michiana Hematology Oncology PC-Niles Completed
Niles, Michigan, United States, 49120
Saint Joseph Mercy Oakland Completed
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron Completed
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan Completed
Saginaw, Michigan, United States, 48601
Marie Yeager Cancer Center Completed
Saint Joseph, Michigan, United States, 49085
Lakeland Hospital Completed
St. Joseph, Michigan, United States, 49085
Saint John Macomb-Oakland Hospital Completed
Warren, Michigan, United States, 48093
United States, Mississippi
University of Mississippi Medical Center Completed
Jackson, Mississippi, United States, 39216
United States, Missouri
Mercy Hospital-Joplin Completed
Joplin, Missouri, United States, 64804
CoxHealth South Hospital Completed
Springfield, Missouri, United States, 65807
Mercy Hospital Springfield Completed
Springfield, Missouri, United States, 65804
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Completed
Springfield, Missouri, United States, 65804
United States, Nebraska
Nebraska Methodist Hospital Completed
Omaha, Nebraska, United States, 68114
United States, Nevada
Women's Cancer Center of Nevada Completed
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Cooper Hospital University Medical Center Completed
Camden, New Jersey, United States, 08103
United States, New York
Winthrop University Hospital Completed
Mineola, New York, United States, 11501
Stony Brook University Medical Center Completed
Stony Brook, New York, United States, 11794
United States, North Carolina
University of North Carolina Completed
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center Completed
Charlotte, North Carolina, United States, 28203
Duke University Medical Center Completed
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences Completed
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center Completed
Akron, Ohio, United States, 44304
University of Cincinnati Completed
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Cancer Center/Fairview Hospital Completed
Cleveland, Ohio, United States, 44111
MetroHealth Medical Center Completed
Cleveland, Ohio, United States, 44109
Case Western Reserve University Completed
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation Completed
Cleveland, Ohio, United States, 44195
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: John H. Farley    877-602-4111      
Principal Investigator: John H. Farley         
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Completed
Columbus, Ohio, United States, 43210
Kettering Medical Center Completed
Kettering, Ohio, United States, 45429
Hillcrest Hospital Cancer Center Completed
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center Completed
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center Completed
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute Completed
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Abington Memorial Hospital Completed
Abington, Pennsylvania, United States, 19001
Geisinger Medical Center Completed
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Center-Cancer Center Hazleton Completed
Hazleton, Pennsylvania, United States, 18201
Geisinger Medical Group Completed
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley Completed
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Rhode Island
Women and Infants Hospital Completed
Providence, Rhode Island, United States, 02905
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 Completed
Houston, Texas, United States, 77030
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 Completed
Bellingham, Washington, United States, 98226
Harrison HealthPartners Hematology and Oncology-Bremerton Completed
Bremerton, Washington, United States, 98310
Harrison Medical Center Completed
Bremerton, Washington, United States, 98310
Providence Regional Cancer Partnership Completed
Everett, Washington, United States, 98201
Skagit Valley Hospital Regional Cancer Care Center Completed
Mount Vernon, Washington, United States, 98273
Harrison HealthPartners Hematology and Oncology-Poulsbo Completed
Poulsbo, Washington, United States, 98370
Group Health Cooperative-Seattle Completed
Seattle, Washington, United States, 98112
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Completed
Seattle, Washington, United States, 98109
Pacific Gynecology Specialists Completed
Seattle, Washington, United States, 98104
Northwest Hospital Completed
Seattle, Washington, United States, 98133
Swedish Medical Center-First Hill Completed
Seattle, Washington, United States, 98122-4307
University of Washington Medical Center Completed
Seattle, Washington, United States, 98195
Seattle Cancer Care Alliance Completed
Seattle, Washington, United States, 98109
Olympic Medical Cancer Care Center Completed
Sequim, Washington, United States, 98384
Rockwood Cancer Treatment Center-DHEC-Downtown Completed
Spokane, Washington, United States, 99204
Cancer Care Northwest - Spokane South Completed
Spokane, Washington, United States, 99202
Tacoma General Hospital Completed
Tacoma, Washington, United States, 98405
Saint Joseph Medical Center Completed
Tacoma, Washington, United States, 98405
Providence Saint Mary Regional Cancer Center Completed
Walla Walla, Washington, United States, 99362
Wenatchee Valley Medical Center Completed
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 Completed
Milwaukee, Wisconsin, United States, 53226
Japan
Tohoku University School of Medicine Completed
Sendai, Aoba-ku, Japan, 980-8574
Kure National Hospital Recruiting
Kure, Hiroshima, Japan, 737
Contact: Kazuhiro Takehara    089-999-1172      
Principal Investigator: Kazuhiro Takehara         
Hokkaido University Hospital Completed
Sapporo, Hokkaido, Japan, 060-8648
Hyogo Cancer Center Completed
Akashi-city, Hyogo, Japan, 673-8558
Iwate Medical University School of Medicine Completed
Morioka, Iwate, Japan, 020-8505
Niigata University Medical and Dental Hospital Recruiting
Niigata City, Niigata, Japan, 951-8520
Contact: John H. Farley    877-602-4111      
Principal Investigator: John H. Farley         
University of the Ryukyus Hospital-Col Health Scnc Completed
Nakagami-gun, Okinawa, Japan, 903-0215
Shizuoka Cancer Center Completed
Shizuoka City, Suntou, Japan, 411-8777
Keio University Completed
Shinjuku-ku, Tokyo, Japan, 160-8582
Kagoshima City Hospital Completed
Kagoshima City, Kagoshima, Japan, 892-8580
Shikoku Cancer Center Completed
Matsuyama, Japan, 791-0280
National Kyushu Cancer Center Completed
Minami-ku, Japan, 811 1395
Jikei University School of Medicine Completed
Minato-ku, Tokyo, Japan, 105-8461
Kinki University Completed
Osaka, Osaka, Japan, 589 8511
Saitama Medical University International Medical Center Completed
Saitama, Japan, 350-1298
National Cancer Center Hospital Completed
Tokyo, Japan, 104 0045
Tottori University Completed
Tottori, Japan, 680-8550
Korea, Republic of
Keimyung University-Dongsan Medical Center Completed
Jung-Ku, Daegu, Korea, Republic of, 700-712
National Cancer Center-Korea Completed
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Samsung Medical Center Completed
Seoul, Korea, Korea, Republic of, 135-710
Asan Medical Center Completed
Seoul, Korea, Republic of, 138-736
Gangnam Severance Hospital Completed
Seoul, Korea, Republic of, 135-720
Korea Cancer Center Hospital Completed
Seoul, Korea, Republic of, 139-706
Seoul National University Hospital Completed
Seoul, Korea, Republic of, 110-744
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: September 2, 2014
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
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 14, 2014