combination chemotherapy in treating patients with ovarian epithelial, fallopian tube, or peritoneal cancer

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

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 ii trial to study the effectiveness of combination chemotherapy in treating patients who have stage ic, stage iib, stage iii, or stage iv ovarian epithelial, fallopian tube, or peritoneal cancer that has not been previously treated.

objectives: * determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in patients with previously untreated stage ic-iv ovarian epithelial, fallopian tube, or peritoneal carcinoma. * determine the response rate of patients treated with this regimen. * determine the time to progression and overall survival of patients treated with this regimen. outline: this is a multicenter study. patients receive paclitaxel iv over 3 hours and carboplatin iv over 30 minutes on day 1 and gemcitabine iv over 30-60 minutes on days 1 and 8. treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. patients are followed at 3 and 6 months. projected accrual: a total of 40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed stage ic-iv ovarian epithelial, fallopian tube, or peritoneal carcinoma * no tumors of low-malignant potential (borderline tumors) * no symptomatic brain metastases patient characteristics: age: * 18 and over performance status: * ecog 0-2 or * karnofsky 70-100% life expectancy: * at least 6 months hematopoietic: * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin greater than 10 g/dl hepatic: * bilirubin no greater than 2 times upper limit of normal renal: * glomerular filtration rate at least 60 ml/min cardiovascular: * no history of congestive heart failure (new york heart association class iii or iv heart disease) even if medically controlled * no myocardial infarction within the past 6 months * no history of atrial or ventricular arrhythmias neurologic: * no history of seizure disorder * no history of cns disorder * no pre-existing motor or sensory neuropathy or symptoms grade 2 or greater other: * no severe concurrent infection * no prior hypersensitivity reaction to products containing cremophor el or compounds chemically related to carboplatin, paclitaxel, or gemcitabine * no complete bowel obstruction * no other concurrent severe medical problems that would preclude study * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * no concurrent immunotherapy * no concurrent wbc transfusions chemotherapy: * no prior chemotherapy * no other concurrent chemotherapy endocrine therapy: * no concurrent hormonal therapy except replacement therapy or steroid antiemetics radiotherapy: * no prior radiotherapy * no concurrent radiotherapy surgery: * no more than 6 weeks since prior definitive surgery

Keywords: stage ii ovarian epithelial cancer stage i ovarian epithelial cancer stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer