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

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: docetaxel

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00085332

GOG-0129N

CDR0000368634

Details and patient eligibility

About

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).

Full description

OBJECTIVES:

• Determine the antitumor activity of docetaxel in patients with recurrent or persistent endometrial carcinoma.
• Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-18 months.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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