Comparison of Gemcitabine v. Gemcitabine Plus Docetaxel in Unresectable Soft Tissue Sarcoma

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Connective Tissue Oncology Society; M.D. Anderson Cancer Center; Massachusetts General Hospital; Mayo Clinic; University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Docetaxel; Gemcitabine

Criteria

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 neutrophil count > 1,500/mm3

• Hemoglobin > 8.0 g/dl

• Platelet count > 100,000/mm3

• Total Bilirubin < upper limit of normal (ULN).

• ALT (SGOT) or AST (SGPT) <5 x ULN.

• Alkaline Phosphatase < 2.5 x ULN.

• Serum creatinine < or equal to 2.0 mg/dL

• Women of child-bearing potential must have a negative serum pregnancy test

• Men and women of child-bearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter (approximately 3 months)

• If the patient is 18 or older, the patient must be capable of providing written, informed consent. If the patient is younger than 18, written and voluntary informed consent from patient's parents or legal guardians and the patient's assent are required.

Exclusion Criteria:

• Soft tissue sarcomas with the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's sarcoma, mesotheliomas

• Active or uncontrolled infection (on antibiotic therapy for acute or chronic infection)

• Prior treatment with gemcitabine or docetaxel

• Peripheral neuropathy > or = grade 2

• History of known hypersensitivity reaction to agents formulated in polysorbate 80, the solubilizing agent for docetaxel [e.g. interferon alpha-2a, children's ibuprofen suspension (Advil), terconazole (Terazol), lamivudine (Epivir), etoposide, amiodarone, vaccines (DtaP, influenza), bupropion (Wellbutrin), Vitamins B12, C+zinc+selenium].

• Uncontrolled, central nervous system metastases