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

NCT ID: NCT00005989

Last Updated: 2011-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2007-07-31

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.

Detailed 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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

tipifarnib

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic Cancer Center

Principal Investigators

Julian Molina, MD

Role: STUDY_CHAIR

Mayo Clinic

Elizabeth Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

U01CA069912

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

982401

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000067978

Identifier Type: -

Identifier Source: org_study_id