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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Tipifarnib

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