Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00055757

Purpose

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:	Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride R 115777 Tipifarnib

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Study Start Date:	November 2002
Study Completion Date:	August 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the response rate of patients with stage IIIB or IV non-small cell lung cancer treated with tipifarnib, gemcitabine, and cisplatin.
Determine the efficacy of this regimen, in terms of time to disease progression, time to treatment failure, and survival, in these patients.
Determine the duration of response in patients treated with this regimen.
Determine the toxicity of this regimen in these patients.
Correlate polymorphism expression in candidate genes with clinical endpoints and toxicity in patients treated with this regimen.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer (NSCLC), meeting one of the following staging criteria:
- Stage IIIB with pleural effusion
- Stage IIIB and not a candidate for combination therapy with radiotherapy and chemotherapy
- Stage IV
Measurable disease
- At least one lesion at least 2.0 cm in diameter
No CNS metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin greater than 10.0 g/dL

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 5 times ULN
AST no greater than 3 times ULN

Renal

Creatinine no greater than 1.5 times ULN

Cardiovascular

No New York Heart Association class III or IV heart disease
No known peripheral vascular disease
No history of deep vein thrombosis

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled infection
No other severe, underlying disease that would preclude study participation
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
No grade 2 or greater preexisting peripheral neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior immunotherapy
No prior biologic therapy
No prior gene therapy

Chemotherapy

See Disease Characteristics
No prior chemotherapy for NSCLC except therapy used as a radiosensitizer (i.e., low-dose weekly cisplatin and carboplatin/paclitaxel with radiotherapy)

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
See Chemotherapy
No prior radiotherapy to more than 25% of the bone marrow

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055757

Locations

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
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
LaGrange Memorial Hospital
LaGrange, Illinois, United States, 60525
Loyola University Medical Center
Maywood, Illinois, United States, 60153-5589
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
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
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-0001
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:

Alex A. Adjei, MD, PhD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Julian R. Molina, M.D., Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00055757 History of Changes
Other Study ID Numbers:	CDR0000271196, P30CA015083, MC0123, 5641
Study First Received:	March 6, 2003
Last Updated:	March 14, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Tipifarnib
Cisplatin

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 12, 2012