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.

Condition	Treatment or Intervention	Phase
recurrent endometrial cancer endometrial papillary carcinoma	Drug: paclitaxel  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  up to  75 Years,  Genders Eligible for Study:  Both

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

Austria
      Allgemeines Krankenhaus der Stadt Wien, Vienna,  A-1090,  Austria
Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium
      Universitair Ziekenhuis Antwerpen, Edegem,  B-2650,  Belgium
Italy
      Ospedale Civile, Voghera (PV),  27058,  Italy
      Ospedale Mauriziano Umberto I, Torino,  10128,  Italy
Portugal
      Hospitais da Universidade de Coimbra (HUC), Coimbra,  3049,  Portugal
Spain
      Hospital Universitasrio San Carlos, Madrid,  28040,  Spain
United Kingdom, England
      Queen Elizabeth Hospital, Gateshead,  England,  NE9 6SX,  United Kingdom

Study chairs or principal investigators

Gerald Gitsch, MD,  Study Chair,  Allgemeines Krankenhaus der Stadt Wien   

Study ID Numbers:  CDR0000068835; EORTC-55961
Record last reviewed:  February 2003
Last Updated:  October 13, 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022620
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08