combination chemotherapy with or without g-csf in treating patients with stage iii, stage iv, or recurrent endometrial cancer

Conditions: Endometrial Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: randomized phase iii trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and g-csf in treating patients who have stage iii, stage iv, or recurrent endometrial cancer.

objectives: * determine whether the addition of paclitaxel, using filgrastim (g-csf) support, to standard doxorubicin/cisplatin chemotherapy produces improvement in the frequency of objective response, progression-free survival, or overall survival in patients with stage iii, stage iv, or recurrent endometrial carcinoma. * compare the toxicities of these two regimens in these patients. outline: this is a randomized, multicenter study. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive doxorubicin iv over 15-30 minutes, followed immediately by cisplatin iv over 1 hour. * arm ii: patients receive doxorubicin and cisplatin as in arm i on day 1. on day 2, patients receive paclitaxel iv over 3 hours. patients also receive filgrastim (g-csf) subcutaneously beginning on day 3 and continuing for at least 10 days. courses are repeated every 21 days. treatment continues for up to 7 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 240 patients (120 per arm) will be accrued for this study within 21 months.

Eligibility criteria:
disease characteristics: * histologically confirmed primary stage iii, stage iv, or recurrent endometrial carcinoma * very poor potential for cure by radiotherapy or surgery alone or in combination * measurable disease * disease in an irradiated field as the only site of measurable disease allowed provided there has been clear progression since completion of radiotherapy patient characteristics: age * 18 and over performance status * gog 0-2 life expectancy * not specified hematopoietic * platelet count at least 100,000/mm\^3 * granulocyte count at least 1,500/mm\^3 hepatic * sgpt no greater than 3 times upper limit of normal * bilirubin normal renal * creatinine no greater than 1.6 mg/dl cardiovascular * lvef at least 50% within past 6 months * no uncontrolled angina * no third-degree or complete heart block unless a pacemaker is in place neurologic * no serious peripheral neuropathy other * no prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer * no uncontrolled infection * no sensitivity to e. coli-derived drug preparations prior concurrent therapy: biologic therapy * prior biologic therapy allowed * no concurrent biologic therapy chemotherapy * no prior cytotoxic chemotherapy, including chemotherapy used for radiation sensitization * no prior chemotherapy for any prior malignancy endocrine therapy * prior hormone therapy allowed * no concurrent hormone therapy radiotherapy * at least 4 weeks since prior radiotherapy to the whole pelvis or to over 50% of the spine surgery * not specified

Keywords: stage iii endometrial carcinoma stage iv endometrial carcinoma recurrent endometrial carcinoma