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