Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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 combining docetaxel, carboplatin, and gemcitabine in treating patients who have previously untreated, newly diagnosed epithelial cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Carboplatin; Docetaxel; Gemcitabine

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, high-risk epithelial tumors of mullerian origin, including: Ovarian epithelial cancer Peritoneal papillary serous cancer Primary fallopian tube cancer Endometrial cancer High-risk is defined as: Any amount of gross residual disease remaining at the time of initial debulking surgery AND/OR Any radiographic or physical exam evidence of disease after surgery AND/OR Disease outside of the abdomen (e.g., malignant pleural effusion) AND/OR Parenchymal liver, spleen, or lung metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:

More than 2 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN SGOT and SGPT no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 35 mL/min Cardiovascular: Acceptable cardiac exam No active cardiac ischemia Pulmonary: Acceptable pulmonary exam No active pulmonary infection or compromise Other: Not pregnant or nursing No peripheral neuropathy grade 2 or greater No other debilitating medical or psychiatric conditions that would preclude study No other malignancy within the past 3 years except limited stage basal or squamous cell skin cancer or carcinoma in situ of the cervix No evidence of infection Adequate bowel function, oral intake, and wound healing ability

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior cytokine therapy for epithelial tumors of mullerian origin Chemotherapy: No more than 1 prior chemotherapy regimen for epithelial tumors of mullerian origin At least 3 years since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior pelvic radiotherapy Surgery: See Disease Characteristics At least 7 days since prior surgery