Conditions: Sarcoma, Soft Tissue
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: no

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 significant morbidity and mortality in young, productive individuals. Although limb preserving surgery and radiation therapy have improved the primary treatment of these tumors, the therapy of advanced, metastatic tumors is unsatisfactory. The purpose of this phase II study is to evaluate the efficacy of treatment with Alimta and gemcitabine given on day 1 of a 14 day cycle to patients with unresectable or metastatic soft tissue sarcomas. Gemcitabine is an established salvage therapy for soft tissue sarcomas in combination with docetaxel. Alimta is a multitargeted antifolate drug which inhibits several folate dependent enzymes required for cell proliferation. Alimta has shown efficacy in several solid tumor types both as a single agent and in combination with other agents. The combination of Alimta and gemcitabine is synergistic and is likely to have efficacy against soft tissue sarcomas. The primary objective of this study is to determine the response rate among patients with unresectable soft tissue sarcoma treated with this combination. Secondary endpoints will evaluate the median survival of this patient population, as well as time to objective tumor response, time to treatment failure and overall survival. The toxicities of this regimen in this population will also be analyzed. Given the desperate need for new agents to treat these patients, a phase II trial of this combination therapy should be pursued.

Arms:
arm 1: IV administration of drugs for 14 days for up to 4 cycles

Interventions: intervention 1: Alimta intervention 2: Gemcitabine
Intervention descriptions: intervention 1: 500 mg/m2 via IV over 10 minutes

A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer. intervention 2: 1000 mg/m2 via IV over 90 minutes

A nucleoside analog used as chemotherapy.

Protocol document: