Alimta Plus Gemcitabine for Advanced Sarcoma

NCT00860015 | Completed Phase 2 Results DMC

• 1 other identifier: AAAB4160
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sarcoma, Soft Tissue

Outcome Measures

Primary Outcomes (1)

• Tumor Best Response Rate

  The best response rate will include patients with both Complete Response and Partial Response after 2 months of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  Two months

Study Arms (1)

Alimta/Gemcitabine

EXPERIMENTAL

IV administration of drugs for 14 days for up to 4 cycles

Drug: Alimta; Drug: Gemcitabine

Interventions

Alimta DRUG

500 mg/m2 via IV over 10 minutes A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer.

Also known as: Pemetrexed

Alimta/Gemcitabine

Gemcitabine DRUG

1000 mg/m2 via IV over 90 minutes A nucleoside analog used as chemotherapy.

Also known as: Gemzar

Alimta/Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Pemetrexed; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Study was deemed as closed/completed early as none of the initial 12 patients treated responded to treatment with alimta/gemcitabine.

Results Point of Contact

• Title: Rober Taub, MD - Vivian and Seymour Milstein Family Prof. of Clinical Medicine
• Organization: Columbia University

rntaubipod@gmail.com

Study Officials

• Robert N Taub, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 11, 2009
• Study Start: August 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: April 1, 2012
• Last Updated: August 25, 2020
• Results First Posted: August 25, 2020

Record last verified: 2020-08

Locations

US (1)