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

Mayo Clinic

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Drug: tipifarnib

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00005989

CDR0000067978

P30CA015083 (U.S. NIH Grant/Contract)

U01CA069912 (U.S. NIH Grant/Contract)

982401 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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