Endometrial Cancer
Conditions
Keywords
recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma
Brief 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).
Detailed 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.
Interventions
DRUGdocetaxel
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion 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
Countries
Australia, Canada, Japan, Norway, United States
Outcome results
None listed