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

NCT00005989 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000067978U01CA069912P30CA015083982401
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IV non-small cell lung cancer

Interventions

tipifarnib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

tipifarnib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Julian Molina, MD

  Mayo Clinic

  STUDY CHAIR

• Elizabeth Johnson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: April 20, 2004
• Study Start: November 1, 2002
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: August 4, 2011

Record last verified: 2011-08

Locations

US (3)