A Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-Naive Non-Small Cell Lung Cancer (NSCLC) - Full Text View

A Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-Naive Non-Small Cell Lung Cancer (NSCLC)

This study is ongoing, but not recruiting participants.

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00424775

Purpose

The clinical study will evaluate safety, tolerability and Pharmacokinetics of MK0683 in combination with carboplatin and paclitaxel in chemotherapy-naive NSCLC patients.

Condition	Intervention	Phase
Neoplasms	Drug: MK0683, vorinostat / Duration of Treatment: 3 Weeks	Phase I

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Carboplatin Paclitaxel Suberoylanilide hydroxamic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	A Phase I Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-Naive Non-Small Cell Lung Cancer (NSCLC)

Further study details as provided by Merck:

Primary Outcome Measures:

Safety

Secondary Outcome Measures:

Pharmacokinetics

Estimated Enrollment:	12
Study Start Date:	January 2007

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chemotherapy-naive patients who are histologically or cytologically diagnosed NSCLC with stage IIIB (not applicable of radical thoracic radiation) or stage IV
Patients with normal organ function and bone marrow function

Exclusion Criteria:

Given radical thoracic radiation for NSCLC or radiation for other than original lesion within 3 weeks
Any peripheral neuropathy above grade 2
Any ascites, pleural effusion or pericardiac effusion which requires treatment
Any uncontrolled concomitant illness
Pregnant or breast-feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424775

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Study ID Numbers:	2007_001
First Received:	January 19, 2007
Last Updated:	July 23, 2007
ClinicalTrials.gov Identifier:	NCT00424775
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck:

Non-Small Cell Lung Cancer (NSCLC)

Study placed in the following topic categories:

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Paclitaxel

Lung Neoplasms

Lung Diseases

Carboplatin

Carcinoma, Non-Small-Cell Lung

Suberoylanilide hydroxamic acid

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008