Comparison of Gemcitabine v. Gemcitabine Plus Docetaxel in Unresectable Soft Tissue Sarcoma (NCT00142571) | Clinical Trial Compass
CompletedPhase 3
Comparison of Gemcitabine v. Gemcitabine Plus Docetaxel in Unresectable Soft Tissue Sarcoma
United States120 participantsStarted 2003-01
Plain-language summary
The purpose of this study is to compare the drug gemcitabine to two drugs, gemcitabine and docetaxel, to find out which treatment is better for people with sarcomas.
Who can participate
Age range10 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically proven soft tissue sarcoma (except the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's Sarcoma, mesotheliomas
* Age \>= 10 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. (ie. 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 failed no more than 3 prior chemotherapy regimens.
* Measurable disease as defined by RECIST. Measurable disease is the presence of at least one measurable lesion. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. A measurable lesion is one that can be accurately measured in at least one dimension with longest diameter \>20 mm using conventional techniques or \>10 mm with spiral CT scan.
* Karnofsky performance status of greater than or equal to 60%
* Peripheral neuropathy, if present, must be \< or = to grade 1
* At least 3 weeks since prior chemotherapy (10 days if the patient was on imatinib, thalidomide, or an interferon)
* At least 3 weeks since prior radiation therapy
* Absolute…
What they're measuring
1
Determine whether the failure rate (defined as progression or death) among patients with unresectable soft tissue sarcoma is improved with gemcitabine plus docetaxel compared with gemcitabine alone