A Phase II Study of Farnesyl Transferase Inhibitor R115777 in Patients With Advanced Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase II Study of Farnesyl Transferase Inhibitor R115777 in Patients With Advanced 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Julian Molina, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000067978
NCT ID:
NCT00005989
Start Date:
November 2002
Completion Date:
July 2007
Related Keywords:
- Lung Cancer
- recurrent non-small cell lung cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Mayo Clinic in Florida | Jacksonville, Florida 32224 |
