Uterine Cancer |
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Clinical Trial: Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma
This study is no longer recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adult soft tissue sarcoma ovarian sarcoma small intestine cancer uterine sarcoma | Drug: docetaxel Drug: filgrastim Drug: gemcitabine Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: colony-stimulating factor therapy Procedure: cytokine therapy | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Digestive Diseases; Soft Tissue Sarcoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Gemcitabine, Docetaxel, and Filgrastim (G-CSF) in Patients With Recurrent or Persistent Unresectable Leiomyosarcoma or Other Soft Tissue Sarcoma
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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
Location Information
Robert Maki, MD, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Publications
Hensley ML, Maki R, Venkatraman E, Geller G, Lovegren M, Aghajanian C, Sabbatini P, Tong W, Barakat R, Spriggs DR. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol. 2002 Jun 15;20(12):2824-31.
Record last reviewed: January 2004
Last Updated: October 13, 2004
Record first received: December 10, 1999
ClinicalTrials.gov Identifier: NCT00004066
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- ACOG's Physician Directory (American College of Obstetricians and Gynecologists)
- Active Coping Helps Gynecologic Cancer Patients' Quality of Life (American Cancer Society)

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