Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: paclitaxel

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00022620

EORTC-55961

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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