Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)
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.
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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
N/A - 75 Years
Accepts Healthy Volunteers
Gerald Gitsch, MD, ,
European Organisation for Research and Treatment of Cancer - EORTC
Gerald Gitsch, MD, Study Chair, Allgemeines Krankenhaus - Universitatskliniken