Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, docetaxel, and filgrastim in treating patients who have recurrent or persistent leiomyosarcoma or soft tissue sarcoma that cannot be removed by surgery.

Detailed Description
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OBJECTIVES: Evaluate the activity of gemcitabine plus docetaxel administered with filgrastim (G-CSF) support, in terms of disease response, in patients with recurrent or persistent unresectable leiomyosarcoma or other soft tissue sarcoma. Determine the tolerability of this regimen in these patients. Correlate response with tumor expression of the apoptosis-regulating proteins bax, bcl-2, and survivin in these patients. OUTLINE: Patients are stratified according to prior radiotherapy to the pelvis (yes vs no). Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by docetaxel IV over 1 hour on day 8 and filgrastim (G-CSF) subcutaneously on days 9-15. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response may receive 2 additional courses of therapy. Patients are followed every 3 months for 1 year or until disease progression. PROJECTED ACCRUAL: A total of 38-82 patients (19-43 with uterine leiomyosarcoma and 19-39 with other soft tissue sarcoma) will be accrued for this study.

Official Title
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A Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma

Conditions
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Ovarian Cancer, Sarcoma, Small Intestine Cancer

Intervention / Treatment
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* Biological: filgrastim
* Drug: docetaxel
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed leiomyosarcoma (LMS) or other soft tissue sarcoma No gastrointestinal stromal tumors, chondrosarcoma, Kaposi's sarcoma, Ewing's sarcoma, osteosarcoma, or mesotheliomas Recurrent or progressive disease defined as an increase in the size of any existing tumor (or the development of new tumors) that is not amenable to definitive surgical therapy No prior chemotherapy OR Failed no more than 2 prior chemotherapy regimens for LMS of the uterus or other soft tissue sarcoma Bidimensionally measurable disease by physical examination or medical imaging techniques Ascites and pleural effusions are not considered measurable disease No uncontrolled CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: No active or uncontrolled infection No other prior malignancy except non-metastatic squamous cell or basal cell skin cancer or non-invasive carcinoma in situ of the cervix No history of grade 3 or 4 peripheral neuropathy Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No prior gemcitabine or docetaxel Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since prior radiotherapy Surgery: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Drug: docetaxel|nan|
|Drug: gemcitabine hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult leiomyosarcoma, recurrent adult soft tissue sarcoma, small intestine leiomyosarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, uterine leiomyosarcoma, ovarian sarcoma, recurrent small intestine cancer, stage IV adult soft tissue sarcoma