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Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer Clinical research trials and Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer. Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer  Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer
Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer
For Condition: ovarian serous cystadenocarcinoma,stage 3 ovarian epithelial cancer,ovarian clear cell cystadenocarcinoma,ovarian endometrioid adenocarcinoma,ovarian mixed epithelial carcinoma,ovarian mucinous cystadenocarcinoma,Brenner Tumor,ovarian undifferentiated adenocarcinoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterRose, Study Chair, Gynecologic Oncology Group
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
CCOP - Baptist Cancer Institute
Memphis, Tennessee, 38117
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, 22908
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, 20007
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
University of Washington Medical Center
Seattle, Washington, 98195-6043
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Women's Cancer Center
Palo Alto, California, 94304
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Additional Information:
Study ID Numbers: CDR0000063600; GOG-152
Study Start Date: June 1994
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002568
Other Ovarian Clear Cell Cystadenocarcinoma Studies:
1. Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
2. Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer
3. Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer
4. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
5. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Related Studies:
Other ovarian clear cell cystadenocarcinoma Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer
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