Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma
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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 | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Sarcoma Small Intestine Cancer |
Biological: filgrastim Drug: docetaxel Drug: gemcitabine hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma |
| Estimated Enrollment: | 82 |
| Study Start Date: | June 1999 |
| Study Completion Date: | October 2003 |
| Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Robert Maki, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00004066 History of Changes |
| Other Study ID Numbers: | 99-027, P30CA008748, MSKCC-99027, NCI-G99-1576 |
| Study First Received: | December 10, 1999 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Leiomyosarcoma Ovarian Neoplasms Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Intestinal Neoplasms Sarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Ileal Diseases Jejunal Diseases Gemcitabine Docetaxel |
ClinicalTrials.gov processed this record on May 21, 2013