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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: | NCT00002813 |
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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cisplatin and vinorelbine in treating patients with refractory or recurrent squamous cell cervical cancer that has not responded to local therapy.
Condition | Intervention | Phase |
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Cervical Cancer |
Drug: cisplatin Drug: vinorelbine ditartrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A LIMITED ACCESS PHASE II TRIAL OF CISPLATIN AND NAVELBINE (VINORELBINE) IN ADVANCED AND RECURRENT SQUAMOUS CELL CARCINOMA OF THE CERVIX |
Estimated Enrollment: | 62 |
Study Start Date: | August 1997 |
Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Determine the activity of cisplatin and vinorelbine in terms of response rate, duration of response, time to treatment failure, and survival in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix.
OUTLINE: This is a multicenter study. Patients receive vinorelbine IV over 6-10 minutes on days 1, 8, 15, and 22 and cisplatin IV over 4 hours beginning after completion of vinorelbine infusion on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within approximately 20 months.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven advanced, persistent, or recurrent squamous cell carcinoma of the cervix that failed local therapy and is considered incurable Bidimensionally measurable abdominal, pelvic, or other lesion by palpation, x- ray, or ultrasound If sole site of measurable disease previously irradiated, then documented disease progression at that site required
PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Karnofsky 60%-100% Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/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 1.4 mg/dL Creatinine clearance at least 50 mL/min if creatinine greater than 1.2 mg/dL Other: No clinically significant infection No preexisting, clinically significant peripheral neuropathy unless due to cancer No other prior or concurrent malignancy except nonmelanomatous skin cancer No psychological, familial, sociological, or geographical condition that would preclude compliance
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy except for radiosensitization Endocrine therapy: Not specified Radiotherapy: See Chemotherapy Recovered from the toxic effects of any recent radiotherapy Surgery: Recovered from the toxic effects of any recent surgery
United States, California | |
Chao Family Comprehensive Cancer Center | |
Orange, California, United States, 92868 | |
United States, Hawaii | |
MBCCOP - Hawaii | |
Honolulu, Hawaii, United States, 96813 | |
United States, Maryland | |
Johns Hopkins Oncology Center | |
Baltimore, Maryland, United States, 21231 | |
United States, Michigan | |
CCOP - Ann Arbor Regional | |
Ann Arbor, Michigan, United States, 48106 | |
United States, New York | |
Cancer Center of Albany Medical Center | |
Albany, New York, United States, 12208 | |
United States, North Carolina | |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | |
Winston-Salem, North Carolina, United States, 27157-1082 | |
United States, South Carolina | |
CCOP - Upstate Carolina | |
Spartanburg, South Carolina, United States, 29303 | |
United States, Tennessee | |
Brookview Research, Inc. | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Chair: | Mitchell Morris, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000064956, GOG-76Z |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002813 History of Changes |
Health Authority: | United States: Federal Government |
recurrent cervical cancer stage IVB cervical cancer cervical squamous cell carcinoma |
Vinblastine Antimitotic Agents Squamous Cell Carcinoma Recurrence Carcinoma Vinorelbine Cisplatin |
Radiation-Sensitizing Agents Epidermoid Carcinoma Tubulin Modulators Neoplasms, Squamous Cell Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Vinblastine Antimitotic Agents Pharmacologic Actions Carcinoma Neoplasms |
Vinorelbine Cisplatin Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Neoplasms, Squamous Cell Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |