Status:
COMPLETED
Alimta Plus Gemcitabine for Advanced Sarcoma
Lead Sponsor:
Columbia University
Conditions:
Sarcoma, Soft Tissue
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In patients with unresectable soft tissue sarcoma, what is the response rate if treated with Alimta and gemcitabine?
Detailed Description
Soft tissue sarcomas represent 0.7% of all malignancies diagnosed in the United States. The peak incidence occurs in children and young adults with a second peak occurring in middle age, resulting in ...
Eligibility Criteria
Inclusion
- Histologically proven soft tissue sarcoma (except the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's Sarcoma, mesotheliomas).
- Age ≥ 18 years
- Recurrent or progressive disease defined as an increase in size of any existing tumor mass, or the development of new tumor mass or masses, which is not amenable to definitive surgical therapy.
- Patients may have had another cancer but there must be convincing clinical evidence that the sarcoma is the disease requiring therapeutic intervention. (i.e. Several sarcoma patients have had had a prior cancer \[Hodgkin's disease or breast cancer\] treated years previously and then developed a clinically active sarcoma.)
- Patients may have received no prior chemotherapy, or may have failed 0-2 prior cytotoxic regimens.
- Measurable disease defined as lesions that can be measured in at least one dimension by physical examination or by means of medical imaging techniques. Ascites and pleural effusions will not be considered measurable disease.
- Karnofsky performance status of greater than or equal to 60%.
- At least 3 weeks since prior chemotherapy or at least 6 weeks since prior radiation therapy.
Exclusion
- Soft tissue sarcomas with the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's sarcoma, mesotheliomas.
- Active or uncontrolled infection
- Prior treatment with gemcitabine or Alimta
- Pregnant or lactating women
- Uncontrolled central nervous system metastases
- Inability to stop treatment with NSAIDs
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00860015
Start Date
August 1 2005
End Date
April 1 2012
Last Update
August 25 2020
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032