Endometrial Cancer
Conditions
Keywords
recurrent endometrial carcinoma, endometrial papillary serous carcinoma
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have refractory or recurrent endometrial cancer.
Detailed description
OBJECTIVES: * Determine the therapeutic activity of paclitaxel in patients with refractory or recurrent endometrial papillary carcinoma. * Determine the objective response and duration of response in patients treated with this regimen. * Determine the acute side effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 12 weeks. PROJECTED ACCRUAL: Approximately 16-29 patients will be accrued for this study.
Interventions
DRUGpaclitaxel
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed endometrial papillary carcinoma (uterine papillary serous carcinoma) * Progressive or recurrent * Bidimensionally measurable disease * Platinum refractory disease, defined by one of the following: * Progression during platinum-based chemotherapy * Stable disease for at least 4 courses of platinum-based chemotherapy * Recurrence within 4 months of platinum-based chemotherapy * No brain involvement or leptomeningeal disease PATIENT CHARACTERISTICS: Age: * 75 and under Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 50 umol/L Renal: * BUN no greater than 8.0 mmol/L * Creatinine no greater than 120 umol/L * Creatinine clearance at least 60 mL/min Other: * Not pregnant * Fertile patients must use effective contraception * HIV negative * No other prior or concurrent malignancy except basal cell carcinoma of the skin * No active bacterial infection (e.g., urinary tract infection) * No uncontrolled or potentially active site of infection (e.g., fistula or abscess) * No psychological, familial, sociological, or geographical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy * At least 1 prior platinum containing regimen * At least 50 mg/m2 per course for a maximum of 28 days for cisplatin * At least 5 times AUC for a maximum of 4 weeks per course for carboplatin * Prior non-taxane-containing chemotherapy allowed Endocrine therapy: * At least 4 weeks since prior hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy * At least 3 months since prior radiotherapy to target lesion * Concurrent radiotherapy allowed for bone pain provided evaluable lesions are outside of irradiation field) Surgery: * Prior surgical management of lymph nodes allowed
Countries
Austria, Belgium, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed