A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00251589

Purpose

The reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib [Tarceva (TM)] that can be given to patients with lung cancer who have relapsed or failed other therapy for the disease. Once the safest maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial will continue vorinostat and erlotinib for up to 8 months. Safety and effectiveness will also be evaluated.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Vorinostat Drug: erlotinib	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Clinical Trial of Oral Vorinostat (MK0683) in Combination With Erlotinib in Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Suberoylanilide hydroxamic acid Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study [ Time Frame: Day 1 to 28 in the Phase I portion of the study ] [ Designated as safety issue: Yes ]
Dose Limiting Toxicity Occurring in Cycle 1 of the Phase II Portion of the Study [ Time Frame: Day 1 to 28 in the Phase II portion of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST) [ Time Frame: Every 57 days beginning with Cycle 3, or more frequently if appropriate ] [ Designated as safety issue: Yes ]
Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST) [ Time Frame: Every 57 days beginning with Cycle 3, or more frequently if appropriate ] [ Designated as safety issue: Yes ]
Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST) [ Time Frame: Every 57 days beginning with Cycle 3, or more frequently if appropriate ] [ Designated as safety issue: Yes ]
Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST) [ Time Frame: Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriate ] [ Designated as safety issue: Yes ]
Progression-Free Survival [ Time Frame: Day 1 to disease progression or death ] [ Designated as safety issue: Yes ]

Enrollment:	23
Study Start Date:	November 2005
Study Completion Date:	December 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort B, Dose Level 1: Experimental	Drug: Vorinostat Vorinostat 200 mg twice a day for 3 days a week. Drug: erlotinib erlotinib 150 mg once a day.
Cohort A, Dose Level 1 (amended): Experimental	Drug: Vorinostat Vorinostat 300 mg once a day for 3 days a week. Drug: erlotinib erlotinib 150 mg once a day.
Cohort B, Dose Level 2: Experimental	Drug: Vorinostat Vorinostat 300 mg twice a day for 3 days a week. Drug: erlotinib erlotinib 150 mg once a day.
Cohort A, Dose Level 1 (original): Experimental	Drug: Vorinostat Vorinostat 400 mg once a day for 21 out of 28 days. Drug: erlotinib erlotinib 150 mg once a day.

Eligibility

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

Criteria

Inclusion Criteria:

Males and females 18 years of age and older with a confirmed diagnosis of non-small-cell lung cancer (NSCLC) who have failed at least one prior treatment for NSCLC.
Patients must have proven disease by CT scan or MRI.
Patients must be at least 4 weeks from any chemotherapy for cancer or from any surgeries or from any treatment using an investigational drug.
Patients must be 2 weeks out from radiation therapy.
At screening the patient must have normal lab results and can not be pregnant.
Women and men must agree to practice adequate birth control during the study.
Patient has the ability to understand and sign the consent form.

Exclusion Criteria:

Patient had prior treatment with vorinostat or erlotinib.
Patient has any of the following conditions: active infections including hepatitis B or C, unstable brain metastases, swallowing difficulties, heart problems, significant eye abnormalities, drug or alcohol abuse, mental illness or pregnancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251589

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_080, MK0683-025
Study First Received:	November 7, 2005
Results First Received:	October 27, 2008
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00251589 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Relapsed Non-Small-Cell Lung Cancer
Refractory Non-Small-Cell Lung Cancer

Additional relevant MeSH terms:

Anticarcinogenic Agents
Thoracic Neoplasms
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Erlotinib

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Vorinostat
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Analgesics, Non-Narcotic
Lung Diseases
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010