Alimta Plus Gemcitabine for Advanced Sarcoma

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

In patients with unresectable soft tissue sarcoma, what is the response rate if treated with Alimta and gemcitabine?

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Gemcitabine; Pemetrexed

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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