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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003316 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients with recurrent or refractory cancer of the uterus.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Evaluation of Gemcitabine in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus |
| Study Start Date: | August 1998 |
OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with recurrent or persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. II. Determine the toxicity of gemcitabine in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. Patients with partial response, complete response, or stable disease receive at least 3 courses of therapy. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine leiomyosarcoma that is refractory to curative therapy or standard treatments Failed local therapeutic measures and considered incurable Measurable disease Not eligible for a higher priority GOG protocol
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: No significant infection At least 5 years since any other invasive malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior gemcitabine No more than 1 prior chemotherapy regimen (single agent or combination therapy) Endocrine therapy: At least 3 weeks since prior endocrine therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and recovered
Contacts and Locations
Show 40 Study Locations| Study Chair: | Katherine Y. Look, MD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
| Study ID Numbers: | CDR0000066265, GOG-131E |
| Study First Received: | November 6, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003316 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent uterine sarcoma uterine leiomyosarcoma |
|
Antimetabolites Immunologic Factors Leiomyosarcoma Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Immunosuppressive Agents Antiviral Agents Recurrence |
Genital Diseases, Female Neoplasms, Connective and Soft Tissue Malignant Mesenchymal Tumor Soft Tissue Sarcomas Radiation-Sensitizing Agents Uterine Sarcoma Sarcoma Uterine Neoplasms Gemcitabine |
|
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Genital Neoplasms, Female Uterine Diseases Enzyme Inhibitors Urogenital Neoplasms |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Genital Diseases, Female Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Sarcoma Uterine Neoplasms Gemcitabine |
