Status:
COMPLETED
Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Uterine Corpus Sarcoma
Uterine Carcinosarcoma
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer. Drugs used in chemotherapy, such as gemcitab...
Detailed Description
OBJECTIVES: I. Determine the antitumor activity of gemcitabine and docetaxel in patients with recurrent or persistent uterine carcinosarcoma. II. Determine the nature and degree of toxicity of this ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00114218
Start Date
March 1 2005
Last Update
January 8 2019
Active Locations (1)
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1
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103