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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-126J |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug |
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
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| Name | Affiliation | Role |
|---|---|---|
| Peter G. Rose, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| CCOP - Greater Phoenix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12586591 | Result | Rose PG, Blessing JA, Ball HG, Hoffman J, Warshal D, DeGeest K, Moore DH. A phase II study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2003 Feb;88(2):130-5. doi: 10.1016/s0090-8258(02)00091-4. |
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| Phoenix |
| Arizona |
| 85006-2726 |
| United States |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033-0800 | United States |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States |
| Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| Women's Cancer Center | Palo Alto | California | 94304 | United States |
| University of Colorado Cancer Center | Denver | Colorado | 80262 | United States |
| Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Emory University Hospital - Atlanta | Atlanta | Georgia | 30322 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342-1701 | United States |
| MBCCOP - Hawaii | Honolulu | Hawaii | 96813 | United States |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637 | United States |
| CCOP - Evanston | Evanston | Illinois | 60201 | United States |
| CCOP - Central Illinois | Springfield | Illinois | 62526 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5265 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | 40536-0084 | United States |
| Johns Hopkins Oncology Center | Baltimore | Maryland | 21287 | United States |
| Medicine Branch | Bethesda | Maryland | 20892 | United States |
| Radiation Oncology Branch | Bethesda | Maryland | 20892 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| CCOP - Ann Arbor Regional | Ann Arbor | Michigan | 48106 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Keesler Medical Center - Keesler AFB | Keesler Air Force Base | Mississippi | 39534-2576 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68131 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Cooper Hospital/University Medical Center | Camden | New Jersey | 08103 | United States |
| Cancer Center of Albany Medical Center | Albany | New York | 12208 | United States |
| State University of New York Health Science Center at Brooklyn | Brooklyn | New York | 11203 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| University of Rochester Cancer Center | Rochester | New York | 14642 | United States |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York | 11790-9832 | United States |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | 27599-7295 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Brookview Research, Inc. | Winston-Salem | North Carolina | 27103 | United States |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157-1082 | United States |
| Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | 45219 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Cleveland Clinic Cancer Center | Cleveland | Ohio | 44195 | United States |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Oklahoma College of Medicine | Oklahoma City | Oklahoma | 73190 | United States |
| CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center | Tulsa | Oklahoma | 74136 | United States |
| CCOP - Columbia River Program | Portland | Oregon | 97213 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| CCOP - Baptist Cancer Institute | Memphis | Tennessee | 38117 | United States |
| Simmons Cancer Center - Dallas | Dallas | Texas | 75235-9154 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Cancer Center, University of Virginia HSC | Charlottesville | Virginia | 22908 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| NCIC-Clinical Trials Group | Kingston | Ontario | K7L 3N6 | Canada |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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