Title
Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)
A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Phase
Phase 2Lead Sponsor
Gynecologic Oncology GroupStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Endometrial CancerIntervention/Treatment
docetaxel ...Study Participants
NoneRATIONALE: 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).
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.
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
