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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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
Experimental: Cohort B, Dose Level 1	Drug: Vorinostat Vorinostat 200 mg twice a day for 3 days a week. Other Names: MK0683 Zolinza® Drug: erlotinib erlotinib 150 mg once a day. Other Name: Tarceva ®
Experimental: Cohort A, Dose Level 1 (amended)	Drug: Vorinostat Vorinostat 300 mg once a day for 3 days a week. Other Names: MK0683 Zolinza® Drug: erlotinib erlotinib 150 mg once a day. Other Name: Tarceva ®
Experimental: Cohort B, Dose Level 2	Drug: Vorinostat Vorinostat 300 mg twice a day for 3 days a week. Other Names: MK0683 Zolinza® Drug: erlotinib erlotinib 150 mg once a day. Other Name: Tarceva ®
Experimental: Cohort A, Dose Level 1 (original)	Drug: Vorinostat Vorinostat 400 mg once a day for 21 out of 28 days. Other Names: MK0683 Zolinza® Drug: erlotinib erlotinib 150 mg once a day. Other Name: Tarceva ®

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:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00251589 History of Changes
Other Study ID Numbers:	2005_080, MK0683-025
Study First Received:	November 7, 2005
Results First Received:	October 27, 2008
Last Updated:	March 9, 2009
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:

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

Lung Diseases
Respiratory Tract Diseases
Vorinostat
Erlotinib
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012