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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00886691 |
Purpose
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and everolimus may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective when given together with or without everolimus in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
PURPOSE: This randomized phase II trial is studying bevacizumab to see how well it works when given with or without everolimus in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer |
Biological: bevacizumab Drug: everolimus Other: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase II Randomized, Double-Blinded Evaluation of Oral Everolimus (RAD001) Plus Bevacizumab vs. Oral Placebo Plus Bevacizumab in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
| Estimated Enrollment: | 150 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral everolimus once daily on days 1-28.
|
Biological: bevacizumab
Given IV
Drug: everolimus
Given orally
|
|
Experimental: Arm II
Patients receive bevacizumab as in arm I and oral placebo once daily on days 1-28.
|
Biological: bevacizumab
Given IV
Other: placebo
Given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to their platinum-free interval (≤ 182 days vs > 182 days), measurable disease status (measurable vs non-measurable or "detectable" disease), and prior treatment with bevacizumab/aflibercept (no vs yes). Patients are randomized to 1 of 2 treatment arms.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed 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 |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer
Meets 1 of the following criteria:
Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest dimension to be recorded) as ≥ 20 mm by chest x-ray OR as ≥ 10 mm by spiral CT scan, MRI, or caliper measurement by clinical exam
Must have ≥ 1 "target lesion" that can be used to assess response to study treatment as defined by RECIST criteria
Detectable disease, defined as non-measurable disease meeting ≥ 1 of the following criteria:
Must have received 1 prior platinum-based chemotherapeutic regimen that contained carboplatin, cisplatin, or another organoplatinum compound for management of the primary disease
Prior biologic (non-cytotoxic) therapy as part of the primary treatment regimen allowed
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
No prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the past 5 years
No prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the past 5 years
Contacts and Locations| United States, Colorado | |
| University of Colorado Cancer Center at UC Health Sciences Center | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Clinical Trials Office - University of Colorado Cancer Center 720-848-0650 | |
| United States, Illinois | |
| Gynecologic Oncology | Recruiting |
| Hinsdale, Illinois, United States, 60521 | |
| Contact: Sudarshan K. Sharma, MD 630-856-6757 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552 | |
| St. Vincent Oncology Center | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Gregory P. Sutton, MD 317-415-6740 | |
| United States, Iowa | |
| McFarland Clinic, PC | Recruiting |
| Ames, Iowa, United States, 50010 | |
| Contact: Clinical Trials Office - McFarland Clinic, PC 515-239-2621 | |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Recruiting |
| Des Moines, Iowa, United States, 50316 | |
| Contact: Clinical Trials Office - John Stoddard Cancer Center at Iowa L 515-241-8704 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Clinical Trials Office - John Stoddard Cancer Center at Iowa M 515-241-6727 | |
| CCOP - Iowa Oncology Research Association | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Robert J. Behrens 515-244-7586 | |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Robert J. Behrens 515-282-2921 | |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Recruiting |
| Des Moines, Iowa, United States, 50314 | |
| Contact: Robert J. Behrens 515-643-8740 | |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Recruiting |
| Des Moines, Iowa, United States, 50314 | |
| Contact: Robert J. Behrens 515-643-8206 | |
| United States, Nebraska | |
| Methodist Estabrook Cancer Center | Recruiting |
| Omaha, Nebraska, United States, 68114 | |
| Contact: Peter C. Morris, MD 402-354-5250 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: William P. Tew 212-639-8895 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 | |
| United States, Ohio | |
| Case Comprehensive Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44106-5065 | |
| Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
| Riverside Methodist Hospital Cancer Care | Recruiting |
| Columbus, Ohio, United States, 43214-3998 | |
| Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C 614-566-4475 | |
| Lake/University Ireland Cancer Center | Recruiting |
| Mentor, Ohio, United States, 44060 | |
| Contact: Steven E. Waggoner, MD 216-844-5011 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| Cancer Care Associates - Saint Francis Campus | Recruiting |
| Tulsa, Oklahoma, United States, 74136-1929 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| United States, Pennsylvania | |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Recruiting |
| Abington, Pennsylvania, United States, 19001 | |
| Contact: Clinical Trials Office - Rosenfeld Cancer Center at Abington M 215-481-2402 | |
| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Clinical Trials Office - Women and Infants Hospital of Rhode I 401-274-1122 | |
| United States, South Carolina | |
| AnMed Cancer Center | Recruiting |
| Anderson, South Carolina, United States, 29621 | |
| Contact: Clinical Trials Office - AnMed Cancer Center 864-512-1000 | |
| United States, Texas | |
| Baylor University Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Clinical Trials Office - Baylor University Medical Center - Da 800-422-9567 | |
| Study Chair: | William P. Tew, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00886691 History of Changes |
| Other Study ID Numbers: | CDR0000640439, GOG-0186G |
| Study First Received: | April 22, 2009 |
| Last Updated: | August 25, 2011 |
| Health Authority: | Unspecified |
|
recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer |
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms by Histologic Type Everolimus Sirolimus Bevacizumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses |