R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00005989

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 R115777 in treating patients who have recurrent or metastatic non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: tipifarnib	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase II Study of Farnesyl Transferase Inhibitor R115777 in Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: R 115777 Tipifarnib

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Study Start Date:	November 2002
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Assess the response rate of patients with recurrent or metastatic non-small cell lung cancer when treated with tipifarnib.
Determine the clinical toxicities of this treatment in these patients.
Assess the overall survival and time to progression of this patient population when treated with this regimen.
Evaluate the inhibition of protein farnesylation in vivo and correlate such inhibition to plasma levels of tipifarnib.
Evaluate the occurrence of CYP450 polymorphisms and relate these to drug toxicity, pharmacokinetics, and response to this treatment in this patient population.

OUTLINE: This is a multicenter study.

Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 12 months.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed recurrent or metastatic non-small cell lung cancer (NSCLC)
Measurable disease
- At least 20 mm in at least one dimension
- Nonmeasurable is defined as any of the following:
  - Bone lesions
  - Leptomeningeal disease
  - Ascites
  - Pleural/pericardial effusion
  - Inflammatory breast disease
  - Lymphangitis cutis/pulmonis
  - Abdominal masses not confirmed and followed by imaging techniques
  - Cystic lesions
No CNS metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

At least 12 weeks

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 2 times upper limit of normal (ULN)
AST no greater than 3 times ULN (no greater than 5 times ULN in case of hepatic metastases)

Renal

Creatinine no greater than 2 times ULN

Cardiovascular

No New York Heart Association class III or IV heart disease

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled infection
No other prior malignancy in past 5 years except adequately treated basal cell or squamous cell skin cancer or other adequately treated noninvasive carcinomas
No other concurrent severe underlying disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior biologic, gene, or immunotherapy

Chemotherapy

No prior chemotherapy for NSCLC except low dose cisplatin as radiosensitizer

Endocrine therapy

Not specified

Radiotherapy

Prior radiotherapy to less than 25% of bone marrow allowed

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005989

Locations

United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:	Julian Molina, MD	Mayo Clinic
Principal Investigator:	Elizabeth Johnson, MD	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 Cancer Center
ClinicalTrials.gov Identifier:	NCT00005989 History of Changes
Other Study ID Numbers:	CDR0000067978, U01CA069912, P30CA015083, 982401
Study First Received:	July 5, 2000
Last Updated:	August 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

recurrent 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
Tipifarnib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012