Mesothelioma Related Clinical Trials:
Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer.

   

Status: Active
Sponsors and Collaborators: Merck
Information provided by: Merck
Government Identifier: NCT00106626

Condition: Neoplasms; Mesothelioma; Non-Small-Cell Lung Carcinoma
Intervention: Drug: Suberoylanilide Hydroxamic Acid (SAHA)


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Purpose:


The purpose of this investigational study is to determine the safety and tolerability of oral suberoylanilide hydroxamic acid when administered in combination with standard doses of pemetrexed and cisplatin for the treatment of advanced solid tumors.
Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer.

Further study details as provided by Merck:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) as measured by unacceptable toxicity. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the safety and tolerability after 14 consecutive day administration followed by 7 days of rest in repeated 21 day cycles as measured by disease progression or unacceptable toxicity. [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   46
Study Start Date:   September 2005
Estimated Study Completion Date:   July 2008

Arms Assigned Interventions
1
vorinostat
Drug: Suberoylanilide Hydroxamic Acid (SAHA)
Dose escalation study starting at vorinostat 200 mg b.i.d. capsules and rising up to vorinostat 400 mg b.i.d. capsules repeated 14 day treatment period in 21 day cycles.

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Eligibility:

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

Criteria

Inclusion Criteria:

  • Patient must be 18 years or older with confirmed diagnosis of a solid tumor for which pemetrexed/cisplatin is acceptable treatment but has yet been previously treated with systemic therapy or has failed standard first-line therapy
  • Has at least 1 measurable lesion
  • Has adequate blood, liver, and kidney functions
  • Has not received any chemotherapy for at least 4 weeks prior to entry in this study
  • Agrees to take adequate measures to prevent pregnancy as outlined in the protocol

Exclusion Criteria:

  • Patient has been treated with other investigational agents with a similar anti-tumor mechanism
  • Patient should not have failed more than 1 prior treatment regimen
  • Patient has active infection or had received IV (intravenous) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs
  • Patient has HIV, hepatitis B or hepatitis C infection
  • Patient is pregnant or breast feeding.
  • Patient has allergy to any component of the study drugs
  • Patient has history of GI (gastrointestinal) surgery or conditions

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106626
Locations
United States, Nevada
Call for Information
Las Vegas, Nevada, United States, 89135

Sponsors and Collaborators
Merck

Investigators
Study Director: Medical Monitor Merck

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Additional Information:

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2005_006, MK0683-012
First Received: March 28, 2005
Last Updated: February 7, 2008
ClinicalTrials.gov Identifier: NCT00106626
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Advanced solid tumors including MPM and NSCLC

Study placed in the following topic categories:
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Lung Neoplasms
Lung Diseases
Mesothelioma
Adenoma
Carcinoma, Non-Small-Cell Lung
Suberoylanilide hydroxamic acid
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Mesothelioma
Anti-Inflammatory Agents
Anticarcinogenic Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents

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