Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00423449

Purpose

This is a clinical trial to determine the safety and tolerability of MK0683 in combination with gemcitabine and cisplatin and/or carboplatin.

Condition	Intervention	Phase
Non-small Cell Lung Cancer	Drug: vorinostat Drug: Comparator: Gemcitabine Drug: Comparator: Cisplatin	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase I Clinical Trial of Vorinostat in Combination With Gemcitabine Plus Platinum in Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride Suberoylanilide hydroxamic acid

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Incidence of dose-limiting toxicities (DLT) due to vorinostat administered in combination with standard dose of gemcitabine plus either cisplatin or carboplatin in patients with advanced stage NSCLC who have not received chemotherapy for advanced disease [ Time Frame: every 21 days ] [ Designated as safety issue: Yes ]
Maximum tolerated dose (MTD) of vorinostat administered in combination with standard doses of gemcitabine plus either cisplatin or carboplatin in patients with advanced stage NSCLC who have not received chemotherapy for advanced disease [ Time Frame: every 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of participants with clinical and laboratory adverse experiences (safety and tolerability) [ Time Frame: every 21 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	61
Study Start Date:	March 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental vorinostat; gemcitabine; cisplatin	Drug: vorinostat Dose escalation study: vorinostat 300-500 mg capsules once daily for 7-14 days in continuous cycles of 21 days Drug: Comparator: Gemcitabine Dose escalation study: Gemcitabine 1000-1250 mg/m2 will be given for 2 days in each 21 day cycle Drug: Comparator: Cisplatin Cisplatin IV 75 mg/m2 will be given for 1 day in each 21 day cycle

Eligibility

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

Criteria

Inclusion Criteria:

Patient must have a histologically-confirmed metastatic or locally advanced non-small cell lung cancer that has not been previously treated with systemic chemotherapy or has received non-platinum and non-gemcitabine based neoadjuvant or adjuvant chemotherapy if the last dose was at least 6 months prior to study enrollment

Exclusion Criteria:

Patient who has had chemotherapy, radiotherapy, or biological therapy prior to entering the study, except for adjuvant or neoadjuvant chemotherapy, as allowed for treatment of a tumor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423449

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_528, MK0683-058
Study First Received:	January 17, 2007
Last Updated:	January 20, 2010
ClinicalTrials.gov Identifier:	NCT00423449 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Merck:

Advanced Stage IIIB/IV Non-Small Cell Lung Cancer

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Sensory System Agents
Lung Neoplasms

Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Vorinostat
Enzyme Inhibitors
Protective Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 08, 2010