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A Phase II Study of Farnesyl Transferase Inhibitor R115777 in Patients With Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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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 ClinicRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Mayo Clinic in FloridaJacksonville, Florida  32224