CompletedNot Applicable

Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus

United States25 participantsStarted 2001-08

Plain-language summary

This is a pilot study of adjuvant therapy for patients with leiomyosarcoma of the uterus that has been completely removed by surgery. "Adjuvant" therapy means that the tumor (the leiomyosarcoma) has been completely removed by surgery; thus, giving further treatment now is done in hopes of decreasing the chance that the tumor will come back (relapse or recur). The main goal of this study is to show that this series of treatments is safe for patients with your type of tumor. In this trial you will be getting drugs that have been approved for use in some types of cancer. In this study we wish to see whether the combination of two chemotherapy drugs, docetaxel and gemcitabine can decrease the chance of your tumor, leiomyosarcoma of the uterus, from coming back (relapsing). We will also be looking at the short-term side effects and risks of the drugs given in this combination to patients with leiomyosarcoma that has been completely resected (removed by surgery). The combination of gemcitabine and docetaxel has been shown to be safe, and it has been shown to decrease the size of leiomyosarcoma tumors in patients with leiomyosarcoma of the uterus that has relapsed, or has continued to grow despite treatment with other chemotherapy drugs.

Who can participate

Age range18 Years

SexFEMALE

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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: * Pathologically confirmed leiomyosarcoma of the uterus, completely resected, stage I, II, III or IV within 8 weeks of surgery to remove the tumor(s). Patients with stage I tumors should have LMS that is considered high-grade by histology. * No prior chemotherapy for LMS * No prior treatment with gemcitabine or docetaxel Age \> 18 years * Karnofsky performance status (KPS) \> or equal to 80% * Pre-treatment absolute neutrophil count \> or equal to 1500/ul, hemoglobin greater than or equal to 8.0 gm/dl, and platelets \> than or equal to 100,000/ul. * Adequate renal documented by serum creatinine \< than or equal to 2.0 mg/dL * Adequate hepatic function: Total serum bilirubin must be within institutional normal limits; transaminases (ALT and AST) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is \< than or equal to ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are \< than or equal to ULN. If peripheral neuropathy is present, it must be less than or equal to grade 1 * Capable of providing written, informed consent * Women with child-bearing potential must have a negative pregnancy test and must consent to using effective contraception while on treatment and for a reasonable period there after. Exclusion Criteria: * Active, or uncontrolled infection * Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of…

What they're measuring

To determine the tolerability of delivering 4 cycles of docetaxel plus gemcitabine.

Timeframe: conclusion of the study

Trial details

NCT IDNCT00614835

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-02