Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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