Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent endometrial carcinoma, endometrial papillary serous carcinoma