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Alimta Plus Gemcitabine as Chemotherapy for Patients With Advanced Sarcoma: A Phase II Clinical

Phase 2
18 Years
Not Enrolling
Sarcoma, Soft Tissue

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Trial Information

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.

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate

Outcome Time Frame:

Two months

Safety Issue:


Principal Investigator

Robert N Taub, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

August 2005

Completion Date:

April 2012

Related Keywords:

  • Sarcoma, Soft Tissue
  • Sarcoma



Columbia University Medical Center New York, New York  10032