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R115777 in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer
This study has been completed.
Study NCT00005989   Information provided by National Cancer Institute (NCI)
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes

July 5, 2000
July 23, 2008
November 2002
 
 
 
Complete list of historical versions of study NCT00005989 on ClinicalTrials.gov Archive Site
 
 
 
R115777 in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer
A Phase II Study of Farnesyl Transferase Inhibitor R115777 in Patients With Advanced Non-Small Cell Lung Cancer

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.

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.

Phase II
Interventional
Treatment
Lung Cancer
Drug: tipifarnib
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005989
 
CDR0000067978, MAYO-982401, NCI-T99-0072
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Alex A. Adjei, MD, PhD Mayo Clinic
National Cancer Institute (NCI)
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP