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

This study has been terminated.

First Received on December 4, 2002. Last Updated on May 31, 2006 History of Changes

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00050336

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung Metastases, Neoplasm	Drug: Lonafarnib (SARASAR)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	A Phase 3 Randomized Study of Lonafarnib in Combination With Paclitaxel and Carboplatin Vs. Placebo in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Lonafarnib

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Estimated Enrollment:	800
Study Start Date:	November 2002
Estimated Study Completion Date:	August 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00050336 History of Changes
Other Study ID Numbers:	P01901
Study First Received:	December 4, 2002
Last Updated:	May 31, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Stage 3b or 4 (metastatic) non-small cell lung cancer

Additional relevant MeSH terms:

Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases

Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 12, 2012