Alimta Plus Gemcitabine as Chemotherapy for Patients With Advanced Sarcoma: A Phase II Clinical
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 limbpreserving 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.
Tumor response rate
Robert N Taub, MD, PhD
United States: Institutional Review Board
|Columbia University Medical Center||New York, New York 10032|