Suberoylanilide Hydroxamic Acid, Fluorouracil, Leucovorin, and Oxaliplatin in Treating Patients With Progressive Metastatic or Unresectable Colorectal Cancer or Other Solid Tumors
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer
About this trial
This is an interventional treatment trial for Recurrent Colon Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed colorectal cancer Metastatic or unresectable disease OR diagnosis of solid tumor No known brain metastases ECOG 0-1 OR Karnofsky 70-100% Life expectancy > 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 WBC ≥ 3,000/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin normal AST and ALT ≤ 3 times upper limit of normal Creatinine normal OR creatinine clearance ≥ 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No ongoing or active infection No neuropathy > grade 1 No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs No psychiatric illness or social situation that would preclude study compliance No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness Prior bevacizumab and/or cetuximab allowed No concurrent routine or prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) More than 4 weeks since prior radiotherapy Recovered from prior therapy At least 2 weeks since prior valproic acid No concurrent combination anti-retroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer therapy
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Experimental
Treatment (vorinostat, mFOLFOX)
Patients receive oral SAHA once or twice daily on days 1-3. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 4 followed by fluorouracil IV over 46 hours on days 4-5. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 10 patients are treated at the MTD.