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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004066 |
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 |
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Ovarian Cancer Sarcoma Small Intestine Cancer |
Biological: filgrastim Drug: docetaxel Drug: gemcitabine hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma |
Estimated Enrollment: | 82 |
Study Start Date: | June 1999 |
OBJECTIVES:
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.
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
Bidimensionally measurable disease by physical examination or medical imaging techniques
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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 |
Study ID Numbers: | CDR0000067268, MSKCC-99027, NCI-G99-1576 |
Study First Received: | December 10, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004066 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Antimetabolites Immunologic Factors Leiomyosarcoma Gonadal Disorders Gastrointestinal Diseases Urogenital Neoplasms Ovarian Diseases Ileal Diseases Docetaxel Genital Diseases, Female Duodenal Neoplasms Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Ileal Neoplasms Ovarian Cancer |
Gemcitabine Duodenal Diseases Endocrine Gland Neoplasms Jejunal Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases Intestinal Diseases Immunosuppressive Agents Antiviral Agents Intestinal Neoplasms Recurrence Malignant Mesenchymal Tumor Digestive System Diseases |
Antimetabolites Anti-Infective Agents Neoplasms, Muscle Tissue Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Leiomyosarcoma Gonadal Disorders Gastrointestinal Diseases Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Ileal Diseases Docetaxel |
Duodenal Neoplasms Genital Diseases, Female Neoplasms, Connective and Soft Tissue Neoplasms by Site Ileal Neoplasms Jejunal Diseases Therapeutic Uses Gemcitabine Duodenal Diseases Endocrine Gland Neoplasms Jejunal Neoplasms Neoplasms by Histologic Type Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female |