Trial Information

Summary: A Phase II Clinical Trial of Alimta Plus Gemcitabine as Chemotherapy for Patients with Advanced Sarcoma

The primary objective of this phase II study is to evaluate the efficacy of treatment with Alimta and gemcitabine in patients with unresectable or metastatic soft tissue sarcomas who have failed 0-2 prior treatment regimens and to study the activity of the two therapeutic agents to determine the median survival for patients with advanced soft tissue sarcoma. Your participation on this study will be completely voluntary. If you decide to withdraw from this study you can also discuss other treatment options with the study doctor.

Patient Inclusion Criteria

1. Histologically proven soft tissue sarcoma (except: gastrointestinal stromal tumors (GIST), Kaposi’s Sarcoma, mesotheliomas).
2. Age > 18 years
3. 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.
4. Patients may have had another cancer but there must be convincing clinical evidence that the sarcoma is the disease requiring therapeutic intervention.
5. Patients may have received no prior chemotherapy, or may have failed 0-2 prior cytotoxic regimens.
6. At least 3 weeks since prior chemotherapy or at least 6 weeks since prior radiation therapy.
7. Patient should have acceptable laboratory results.
8. Men and women of child-bearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter (approximately 3 months).
9. Capable of providing written, informed consent.

Patient Exclusion Criteria

1. Soft tissue sarcomas with the following histologies: gastrointestinal stromal tumors (GIST), Kaposi’s sarcoma, mesotheliomas.
2. Active or uncontrolled infection
3. Prior treatment with gemcitabine or Alimta
4. Pregnant or lactating women
5. Uncontrolled central nervous system metastases
6. Inability to stop treatment with NSAIDs

If you would like to learn more about participating in this study, please send an e-mail message using the form below.