Alimta Plus Gemcitabine for Advanced Sarcoma
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ClinicalTrials.gov Identifier: NCT00860015 |
Recruitment Status :
Completed
First Posted : March 11, 2009
Results First Posted : August 25, 2020
Last Update Posted : August 25, 2020
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Condition or disease | Intervention/treatment | Phase |
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Sarcoma, Soft Tissue | Drug: Alimta Drug: Gemcitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Alimta Plus Gemcitabine as Chemotherapy for Patients With Advanced Sarcoma: A Phase II Clinical |
Study Start Date : | August 2005 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | April 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Alimta/Gemcitabine
IV administration of drugs for 14 days for up to 4 cycles
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Drug: Alimta
500 mg/m2 via IV over 10 minutes A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer. Other Name: Pemetrexed Drug: Gemcitabine 1000 mg/m2 via IV over 90 minutes A nucleoside analog used as chemotherapy. Other Name: Gemzar |
- Tumor Best Response Rate [ Time Frame: Two months ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 therapy.
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860015
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 |
Principal Investigator: | Robert N Taub, MD, PhD | Columbia University |
Responsible Party: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00860015 |
Other Study ID Numbers: |
AAAB4160 |
First Posted: | March 11, 2009 Key Record Dates |
Results First Posted: | August 25, 2020 |
Last Update Posted: | August 25, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Gemcitabine Pemetrexed Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |