Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)

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

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with recurrent or persistent endometrial carcinoma (cancer).

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

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed endometrial carcinoma

• Recurrent or persistent disease

• Refractory to curative or standard therapy

• Measurable disease

• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• At least 1 target lesion

• Tumors within a previously irradiated field are not considered target lesions

• Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment

• One additional non-cytotoxic regimen for recurrent or persistent disease allowed, including monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction

• Ineligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• SGOT ≤ 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2.5 times ULN

• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No neuropathy (sensory and motor) ≥ grade 2

• No active infection requiring antibiotics

• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• At least 3 weeks since prior biologic or immunologic therapy for malignant tumor

• No concurrent prophylactic growth factors

• No concurrent prophylactic thrombopoietic agents

Chemotherapy

• See Disease Characteristics

• Recovered from prior chemotherapy

• No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic drugs)

Endocrine therapy

• At least 1 week since prior hormonal therapy for malignant tumor

• Concurrent hormone replacement therapy allowed

Radiotherapy

• See Disease Characteristics

• Recovered from prior radiotherapy

Surgery

• Recovered from prior surgery

Other

• At least 3 weeks since other prior therapy for malignant tumor

• No prior anticancer therapy that would preclude current protocol therapy

• No concurrent amifostine or other protective reagents