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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00055757 |
RATIONALE: Drugs used in chemotherapy such as gemcitabine and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining tipifarnib with combination chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining tipifarnib with gemcitabine and cisplatin in treating patients who have stage III or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: tipifarnib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of R11577, a Farnesyl Transferase Inhibitor, in Combination With Gemcitabine and Cisplatin in Advanced Non-Small Cell Lung Cancer (NSCLC) |
Study Start Date: | November 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily on days 1-14, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with at least stable disease may continue to receive oral tipifarnib alone twice daily on days 1-14.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 5 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC), meeting one of the following staging criteria:
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259 | |
United States, District of Columbia | |
Howard University College of Medicine | |
Washington, District of Columbia, United States, 20059 | |
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States, 32224 | |
United States, Illinois | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Decatur Memorial Hospital Cancer Care Institute | |
Decatur, Illinois, United States, 62526 | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153-5589 | |
Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
LaGrange Memorial Hospital | |
LaGrange, Illinois, United States, 60525 | |
Louis A. Weiss Memorial Hospital | |
Chicago, Illinois, United States, 60640 | |
Evanston Northwestern Health Care - Evanston Hospital | |
Evanston, Illinois, United States, 60201-1781 | |
Oncology/Hematology Associates of Central Illinois, P.C. | |
Peoria, Illinois, United States, 61602 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Indiana | |
Fort Wayne Medical Oncology and Hematology, Incorporated | |
Fort Wayne, Indiana, United States, 46885-5099 | |
Michiana Hematology-Oncology, P.C. - South Bend | |
South Bend, Indiana, United States, 46617 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201 | |
Oncology Care Associates, P.L.L.C. | |
Saint Joseph, Michigan, United States, 49085 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 | |
United States, Wisconsin | |
Medical College of Wisconsin Cancer Center | |
Milwaukee, Wisconsin, United States, 53226 | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-0001 |
Study Chair: | Alex A. Adjei, MD, PhD | Mayo Clinic |
Study ID Numbers: | CDR0000271196, MAYO-MC0123, NCI-5641 |
Study First Received: | March 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00055757 History of Changes |
Health Authority: | United States: Federal Government |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Immunologic Factors Immunosuppressive Agents Antiviral Agents Carcinoma Respiratory Tract Diseases Cisplatin |
Radiation-Sensitizing Agents Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Tipifarnib |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Gemcitabine |
Tipifarnib Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |