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

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

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Carboplatin Paclitaxel Lonafarnib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

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

Keywords provided by Schering-Plough:

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

Study placed in the following topic categories:

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Paclitaxel

Lung Neoplasms

Lung Diseases

Neoplasm Metastasis

Carboplatin

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Mitosis Modulators

Antimitotic Agents

Pharmacologic Actions

Neoplasms

Neoplastic Processes

Neoplasms by Site

Pathologic Processes

Therapeutic Uses

Tubulin Modulators

Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 15, 2008

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