A Phase II Study of Docetaxel and Carboplatin for Suboptimally Debulked Stage III or Stage IV Ovarian and Fallopian Tube Carcinoma
carboplatin
+ docetaxel
Urogenital Diseases+21
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: May 1, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: Evaluate the response rate, duration of response, and progression-free and overall survival of previously untreated patients with suboptimally debulked stage III or stage IV ovarian carcinoma, fallopian tube carcinoma, papillary serous cancer of the uterus, or primary peritoneal carcinoma treated with docetaxel and carboplatin. Evaluate the feasibility and toxicity of this regimen in these patients. Evaluate the effect of this regimen on quality of life of these patients. OUTLINE: This is an open-label study. Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to therapy and then after every 3 courses of chemotherapy. PROJECTED ACCRUAL: Approximately 14-40 patients will be accrued for this study within 2.5 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed previously untreated ovarian cancer, fallopian tube carcinoma, papillary serous cancer of the uterus, or primary peritoneal carcinoma Suboptimally debulked stage III or suboptimally or optimally debulked stage IV Measurable or evaluable disease CNS lesions, lytic bone lesions, and radiated lesions (unless there is documented progression after radiotherapy) are not considered measurable CA 125 levels above 49 units/mL in the absence of cirrhosis or nonmalignant gross ascites are considered evaluable Ineligible for other high-priority national or institutional study PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: More than 2 months Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and/or SGPT less than 2.5 times ULN OR SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN OR Alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT no greater than ULN No SGOT and/or SGPT greater than 1.5 times ULN with alkaline phosphatase greater than 2.5 times ULN Alkaline phosphatase less than 350 U/L Renal: BUN less than 1.5 times normal Creatinine less than 1.5 times ULN Other: No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or skin cancer No other serious medical or psychiatric illness Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy Radiotherapy: See Disease Characteristics No prior radiotherapy Surgery: See Disease Characteristics
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, United StatesOpen Herbert Irving Comprehensive Cancer Center at Columbia University in Google Maps