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
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma, Soft Tissue||Drug: Alimta Drug: Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
IV administration of drugs for 14 days for up to 4 cycles
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
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.
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|