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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00031629 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim or pegfilgrastim 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: This phase II trial is studying how well combination chemotherapy plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent cancer of the uterus.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: docetaxel Drug: filgrastim Drug: gemcitabine hydrochloride Drug: pegfilgrastim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Evaluation Of Docetaxel And Gemcitabine Plus G-CSF In The Treatment Of Recurrent Or Persistent Leiomyosarcoma Of The Uterus |
Estimated Enrollment: | 51 |
Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and filgrastim (G-CSF) subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed uterine leiomyosarcoma
At least 1 unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Martee L. Hensley, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000069206, GOG-0131G |
Study First Received: | March 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00031629 |
Health Authority: | United States: Federal Government |
recurrent uterine sarcoma uterine leiomyosarcoma |
Leiomyosarcoma Malignant mesenchymal tumor Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Recurrence Soft tissue sarcomas |
Docetaxel Genital Diseases, Female Neoplasms, Connective and Soft Tissue Sarcoma Uterine Neoplasms Uterine sarcoma Gemcitabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |