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Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer  Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
For Condition: ovarian mucinous cystadenocarcinoma,stage 4 ovarian epithelial cancer,ovarian mixed epithelial carcinoma,ovarian endometrioid adenocarcinoma,ovarian serous cystadenocarcinoma,peritoneal cavity cancer,stage 3 ovarian epithelial cancer,ovarian undifferentiated adenocarcinoma,ovarian clear cell cystadenocarcinoma,Brenner Tumor
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 may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer.
Details: OBJECTIVES: I. Determine the feasibility of administering multiple courses of carboplatin and topotecan without excessive dose modification or course delay in patients with previously untreated ovarian epithelial or primary peritoneal carcinoma. II. Describe the response rate and progression-free interval in these patients with this treatment regimen. III. Determine pharmacokinetic and pharmacodynamic parameters related to the sequence of carboplatin and topetecan administration in these patients. PROTOCOL OUTLINE: Patients are assigned to one of three treatment regimens. Regimen I: Patients receive carboplatin IV over 30 minutes on day 1 followed by topotecan IV over 30 minutes on days 1-3. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen II: Patients receive topotecan IV over 30 minutes on days 1-3 followed by carboplatin IV over 30 minutes on day 3. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen III: Patients receive topotecan IV over 30 minutes on days 1-5 followed by carboplatin IV over 30 minutes on day 5. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then every 3 months for 1 year. PROJECTED ACCRUAL: A total of 15-80 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage III or IV ovarian epithelial or primary peritoneal carcinoma - Prior surgery required within the past 12 weeks - Either optimal (no greater than 1 cm residual disease) or suboptimal residual disease following initial surgery - No ovarian epithelial tumors of low malignant potential (borderline tumor) - The following histologic epithelial cell types are eligible: Serous adenocarcinoma Mucinous adenocarcinoma; Clear cell adenocarcinoma; Transitional cell carcinoma; Adenocarcinoma not otherwise specified Endometrioid adenocarcinoma; Undifferentiated carcinoma; Mixed epithelial carcinoma; Malignant Brenner tumor --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: See Disease Characteristics - Other: No prior cancer treatment that contraindicates study protocol --Patient Characteristics-- - Age: Not specified - Performance status: GOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least lower limit of normal - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT and alkaline phosphatase no greater than 2.5 times ULN; No acute hepatitis - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No unstable angina; No myocardial infarction within past 6 months; Abnormal cardiac conduction (e.g., bundle branch block, heart block) allowed if stable for past 6 months - Other: No septicemia or severe infection; No severe gastrointestinal bleeding; No concurrent or prior invasive malignancies within past 5 years except nonmelanoma skin cancer; No greater than grade 1 neuropathy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelBookman, Study Chair, Gynecologic Oncology Group
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
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
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Tufts University School of Medicine
Boston, Massachusetts, 02111
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Tampa Bay Cancer Consortium
Saint Petersburg, Florida, 33701
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Ellis Fischel Cancer Center
Columbia, Missouri, 65203
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Radiation Oncology Branch
Bethesda, Maryland, 20892
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Additional Information:
Study ID Numbers: CDR0000067547; GOG-9906
Study Start Date: February 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005026
Other Ovarian Serous Cystadenocarcinoma Studies:
1. TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
2. Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
3. Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian 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 With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer
Related Studies:
Other ovarian serous cystadenocarcinoma Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
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