Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus
Recurrent Uterine Corpus Sarcoma, Uterine Corpus Leiomyosarcoma
About this trial
This is an interventional treatment trial for Recurrent Uterine Corpus Sarcoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed uterine leiomyosarcoma Recurrent or persistent disease that is refractory to curative therapy or established treatments Must have received 1 prior chemotherapy regimen that may include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques At least 10 mm by spiral CT scan Lesions within a previously irradiated field allowed provided progression is documented or biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy Ineligible for a high priority GOG protocol Performance status - GOG 0-2 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.1 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Creatinine no greater than 1.5 times ULN No active infection requiring antibiotics No motor or sensory neuropathy greater than grade 1 No other malignancy within the past 5 years except nonmelanoma skin cancer Not pregnant Negative pregnancy test Fertile patients must use effective contraception No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) for recurrent or persistent disease At least 3 weeks since prior biologic or immunologic therapy for this disease See Disease Characteristics See Biologic therapy At least 3 weeks since prior chemotherapy and recovered No prior docetaxel or gemcitabine No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial regimens No prior chemotherapy for another malignancy that would preclude study At least 1 week since prior hormonal therapy for this disease Concurrent hormone replacement therapy allowed See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered See Disease Characteristics Recovered from prior recent surgery At least 3 weeks since other prior therapy for this disease No concurrent amifostine or other protective agents
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)
Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and G-CSF SC on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.