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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004037 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory ovarian or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: docetaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Evaluation of Docetaxel in Recurrent, Platinum Resistant, Refractory and Paclitaxel Refractory Ovarian Cancer and Primary Peritoneal Carcinoma |
| Study Start Date: | June 1998 |
OBJECTIVES: I. Estimate the antitumor activity of docetaxel in patients with paclitaxel- and platinum-resistant, recurrent or refractory, ovarian epithelial or primary peritoneal cancer who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of docetaxel in this patient population.
OUTLINE: Patients receive docetaxel as a 1 hour continuous intravenous infusion. Courses are repeated every 21 days. Treatment continues in the absence of unacceptable toxic effects or disease progression. All patients are followed every 3 months for 2 years, every 6 months for 3 years, and then until death.
PROJECTED ACCRUAL: A total of 23-56 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory ovarian epithelial or peritoneal cancer Platinum resistant AND paclitaxel resistant Progressed on or within 6 months of completing therapy with paclitaxel and platinum either alone or in combination Bidimensionally measurable disease (excludes ascites and pleural effusions) Brain metastases allowed provided that other measurable disease exists and brain lesions required no therapy for 6 months and are not life threatening Not eligible for higher priority GOG protocol
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 1.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No significant infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E) No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Must have had at least 1 prior platinum based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound Must have had at least 1 prior paclitaxel based chemotherapeutic regimen 1 or 2 prior chemotherapy regimens containing platinum and paclitaxel allowed Recovered from toxic effects No prior docetaxel Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Recovered from effects of recent surgery Other: At least 3 weeks since any prior therapy directed at the malignant tumor No prior cancer treatment that contraindicates this protocol therapy
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| CCOP - Greater Phoenix | |
| Phoenix, Arizona, United States, 85006-2726 | |
| United States, California | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033-0800 | |
| Women's Cancer Center | |
| Palo Alto, California, United States, 94304 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Vincent T. Lombardi Cancer Research Center, Georgetown University | |
| Washington, District of Columbia, United States, 20007 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Hawaii | |
| MBCCOP - Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| CCOP - Central Illinois | |
| Springfield, Illinois, United States, 62526 | |
| CCOP - Evanston | |
| Evanston, Illinois, United States, 60201 | |
| Rush-Presbyterian-St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5265 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Albert B. Chandler Medical Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0084 | |
| United States, Maryland | |
| Johns Hopkins Oncology Center | |
| Baltimore, Maryland, United States, 21287 | |
| Medicine Branch | |
| Bethesda, Maryland, United States, 20892 | |
| Radiation Oncology Branch | |
| Bethesda, Maryland, United States, 20892 | |
| United States, Massachusetts | |
| University of Massachusetts Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| Keesler Medical Center - Keesler AFB | |
| Keesler AFB, Mississippi, United States, 39534-2576 | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68131 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| Cooper Hospital/University Medical Center | |
| Camden, New Jersey, United States, 08103 | |
| United States, New York | |
| Cancer Center of Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| State University of New York Health Science Center at Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| State University of New York Health Sciences Center - Stony Brook | |
| Stony Brook, New York, United States, 11790-9832 | |
| University of Rochester Cancer Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Brookview Research, Inc. | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| Barrett Cancer Center, The University Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| Cleveland Clinic Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| United States, Oklahoma | |
| CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center | |
| Tulsa, Oklahoma, United States, 74136 | |
| University of Oklahoma College of Medicine | |
| Oklahoma City, Oklahoma, United States, 73190 | |
| United States, Oregon | |
| CCOP - Columbia River Program | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Pennsylvania Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, Tennessee | |
| CCOP - Baptist Cancer Institute | |
| Memphis, Tennessee, United States, 38117 | |
| United States, Texas | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Cancer Center, University of Virginia HSC | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| Tacoma General Hospital | |
| Tacoma, Washington, United States, 98405 | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| Canada, Ontario | |
| NCIC-Clinical Trials Group | |
| Kingston, Ontario, Canada, K7L 3N6 | |
| Study Chair: | Peter G. Rose, MD | The Cleveland Clinic |
More Information
| Study ID Numbers: | CDR0000066369, GOG-126J |
| Study First Received: | December 10, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004037 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer peritoneal cavity cancer |
|
Digestive System Neoplasms Ovarian Neoplasms Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms Pharmacologic Actions |
Adnexal Diseases Docetaxel Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Therapeutic Uses Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |