Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer
Recurrent Uterine Corpus Sarcoma, Uterine Carcinosarcoma
About this trial
This is an interventional treatment trial for Recurrent Uterine Corpus Sarcoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed uterine carcinosarcoma Malignant mixed Müllerian tumor, homologous or heterologous type Recurrent or persistent disease Progressive disease after prior local therapy Measurable disease, defined as ≥ 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 except documented progression or biopsy to confirm persistence at least 90 days after completion of radiation therapy Received 1, and only 1, prior chemotherapy regimen for carcinosarcoma Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment Ineligible for higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population) Performance status - GOG 0-2 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 times upper limit normal (ULN) SGOT ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Creatinine ≤ 1.5 times ULN No severe pulmonary disease requiring oxygen supplementation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring antibiotics No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No neuropathy (sensory or motor) > grade 1 At least 3 weeks since prior biologic therapy or immunotherapy for the malignancy No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for recurrent or persistent disease Recovered from prior chemotherapy No more than 1 prior cytotoxic chemotherapy regimen, either as a single agent or combination therapy No prior docetaxel or gemcitabine At least 1 week since prior hormonal therapy for the malignancy Concurrent hormone replacement therapy allowed Recovered from prior radiotherapy Recovered from prior surgery At least 3 weeks since other prior therapy for the malignancy No prior cancer treatment that would preclude study therapy
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (gemcitabine hydrochloride, docetaxel)
Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.