Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with surgery may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and cisplatin with or without surgery in treating patients with stage III ovarian epithelial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: cisplatin Drug: paclitaxel Procedure: conventional surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A PHASE III RANDOMIZED STUDY OF CISPLATIN (NSC #119875) AND TAXOL (PACLITAXEL) (NSC #125973) WITH INTERVAL SECONDARY CYTOREDUCTION VERSUS CISPLATIN AND PACLITAXEL IN PATIENTS WITH SUBOPTIMAL STAGE III & IV EPITHELIAL OVARIAN CARCINOMA |
| Estimated Enrollment: | 470 |
| Study Start Date: | June 1994 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Determine whether secondary cytoreductive surgery improves the progression-free interval and survival in patients with suboptimally resected stage III ovarian epithelial carcinoma treated with paclitaxel/cisplatin. II. Determine the morbidity of secondary cytoreductive surgery in these patients. III. Assess prospectively the quality of life (QOL) of these patients and determine whether secondary cytoreductive surgery affects QOL.
OUTLINE: Randomized study. Following treatment on Regimen A, patients with stable or objective response are randomized to Arms I and II. Regimen A: 2-Drug Combination Chemotherapy. Paclitaxel (Bristol-Myers), Taxol, NSC-125973; Cisplatin, CDDP, NSC-119875. Arm I: Surgery followed by 2-Drug Combination Chemotherapy. Laparotomy with resection of residual disease; followed by Taxol/CDDP. Arm II: 2-Drug Combination Chemotherapy. Taxol; CDDP.
PROJECTED ACCRUAL: Approximately 470 patients will be entered over 20 months to provide 400 evaluable patients.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer Stage III disease, i.e.: Greater than 1 cm residual intraperitoneal disease following exploratory laparotomy with maximum debulking Laparoscopic resection alone insufficient The following histologies are eligible: Serous adenocarcinoma Transitional cell carcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Adenocarcinoma Endometrioid tumor Adenocarcinoma NOS Malignant Brenner's tumor No unclassified ovarian cancer (i.e., unexplored tumors thought to be of ovarian origin or tumors not verified as arising from ovarian stroma) No borderline (grade 0) or "probably malignant" carcinoma Measurable disease preferred Patients eligible for this protocol are also eligible for protocol GOG-136
PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no more than 1.5 times normal ALT, AST, and GGT no more than 3 times normal Alkaline phosphatase no more than 3 times normal LDH no more than 3 times normal Renal: Creatinine no more than 2.0 mg/dL Cardiovascular: No history of congestive heart failure No myocardial infarction within 6 months No unstable angina Other: No septicemia or severe infection No acute hepatitis No severe gastrointestinal bleeding No second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Effective contraception required of fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No more than 6 weeks since staging surgery
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 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033-0800 | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| Women's Cancer Center | |
| Palo Alto, California, United States, 94304 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5408 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Lombardi Cancer 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 | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Hawaii | |
| MBCCOP - Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Rush-Presbyterian-St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| 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, 21231 | |
| United States, Massachusetts | |
| University of Massachusetts Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Cooper Hospital/University Medical Center | |
| Camden, New Jersey, United States, 08103 | |
| Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07962-1956 | |
| United States, New York | |
| Cancer Center of Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| State University of New York Health Science Center at Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| University of Rochester Cancer Center | |
| Rochester, New York, United States, 14642 | |
| State University of New York Health Sciences Center - Stony Brook | |
| Stony Brook, New York, United States, 11790-7775 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| United States, Ohio | |
| Barrett Cancer Center, The University Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| 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 | |
| Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| CCOP - Baptist Cancer Institute | |
| Memphis, Tennessee, United States, 38117 | |
| Brookview Research, Inc. | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Virginia | |
| Cancer Center, University of Virginia HSC | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| Tacoma General Hospital | |
| Tacoma, Washington, United States, 98405 | |
| Study Chair: | Peter G. Rose, MD | The Cleveland Clinic |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00002568 History of Changes |
| Other Study ID Numbers: | CDR0000063600, GOG-152 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 20, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III ovarian epithelial cancer ovarian undifferentiated adenocarcinoma ovarian mixed epithelial carcinoma ovarian serous cystadenocarcinoma |
ovarian mucinous cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian clear cell cystadenocarcinoma Brenner tumor |
Additional relevant MeSH terms:
|
Ovarian 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 Neoplasms by Histologic Type |
Cisplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013