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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005989
Recruitment Status : Completed
First Posted : April 20, 2004
Last Update Posted : August 4, 2011
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

Brief Summary:

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 or disease Intervention/treatment Phase
Lung Cancer Drug: tipifarnib Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of Farnesyl Transferase Inhibitor R115777 in Patients With Advanced Non-Small Cell Lung Cancer
Study Start Date : November 2002
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


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


  • 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)


  • Creatinine no greater than 2 times ULN


  • No New York Heart Association class III or IV heart disease


  • 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


Biologic therapy

  • No prior biologic, gene, or immunotherapy


  • No prior chemotherapy for NSCLC except low dose cisplatin as radiosensitizer

Endocrine therapy

  • Not specified


  • Prior radiotherapy to less than 25% of bone marrow allowed


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005989

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)
Study Chair: Julian Molina, MD Mayo Clinic
Principal Investigator: Elizabeth Johnson, MD Mayo Clinic

Responsible Party: Julian R. Molina, M.D., Ph.D., Mayo Clinic Cancer Center Identifier: NCT00005989     History of Changes
Other Study ID Numbers: CDR0000067978
U01CA069912 ( U.S. NIH Grant/Contract )
P30CA015083 ( U.S. NIH Grant/Contract )
982401 ( Other Identifier: Mayo Clinic IRB )
First Posted: April 20, 2004    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: August 2011

Keywords provided by Mayo Clinic:
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents