Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Drug: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be 18 years or older with confirmed diagnosis of a solid tumor for which pemetrexed and cisplatin is acceptable treatment and have received no more than 2 prior systemic therapies 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 from Cohorts A and B has received pemetrexed or cisplatin within the past 6 months and from Cohorts C and D have received pemetrexed within the past 6 months Patient from Cohorts A and B has preexisting Grade 2 or higher neuropathy and from Cohorts C and D have Grade 3 or higher neuropathy 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) | Drug: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin<br>* Dose escalation study starting with vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) capsules 200 mg b.i.d. in combination with Pemetrexed and Cisplatin (see table for Reporting Groups).<br>* Other names: Suberoylanilide Hydroxamic Acid (SAHA);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level | MTD was determined by the occurrence of DLTs during the first treatment cycle. DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. The dose level is equal to the MTD if < 2 patients experience a DLT and is also the highest tolerated dose level in the cohort. | Cycle 1 (21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as Measured by the Number of Participants With Disease Progression | Number of participants with disease progression (protocol-mandated reason for discontinuation). Disease progression was determined by the principle investigator. | Any time during 8 cycle treatment period through 30 days after. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced solid tumors including MPM and NSCLC