Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)(TERMINATED)

• Status: Terminated
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the overall survival of patients diagnosed with Stage 3b or 4 non-small cell lung cancer (NSCLC) treated with an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 66336) in combination with paclitaxel and carboplatin with that of patients treated with placebo in combination with paclitaxel and carboplatin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Carboplatin; Lonafarnib; Paclitaxel

Criteria

Inclusion Criteria:

• Male or female

• Histologically or cytologically 3b or 4 (metastatic) non-small cell lung cancer. Patients must meet any subcriteria as detailed in the protocol.

• Age greater than or equal to 18 years old

• ECOG performance status of 0 to 1

• Prior diagnosis of brain metastases from NSCLC eligible provided that the brain metastases have been adequately treated, patient is neurologically stable and no new or progressive brain metastases identified.

• Meets protocol requirements for specified laboratory values

• Written informed consent

• Appropriate use of effective contraception if of childbearing potential

• Prior basal cell carcinoma or carcinoma in-situ of the cervix are eligible provided they have been treated with no evidence of disease

Exclusion Criteria:

• Prior chemotherapy for any stage of NSCLC

• Prior surgery or radiation therapy within the last 2 weeks or incomplete recovery from prior procedures or therapy

• Concurrent treatment or treatment within the last 2 years for any other malignancy

• Grade 2 or greater nausea or Grade 1 or greater vomiting (despite antiemetic medication)

• Medical conditions that would interfere with taking oral medications

• Patients with bone metastases as the only site of disease

• Pregnant or nursing women

• Known HIV positivity or AIDS-related illness

• Patients with significant QTc prolongation at baseline