Suberoylanilide Hydroxamic Acid, Fluorouracil, Leucovorin, and Oxaliplatin in Treating Patients With Progressive Metastatic or Unresectable Colorectal Cancer or Other Solid Tumors
Completed · Phase 1
Conditions studied: Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer, Stage III Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer, Unspecified Adult Solid Tumor, Protocol Specific
In brief
This phase I trial is studying the side effects and best dose of suberoylanilide hydroxamic acid when given together with fluorouracil, leucovorin, and oxaliplatin in treating patients with progressive metastatic or unresectable colorectal cancer or solid tumor. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Key facts
- Study ID
- NCT00138177
- Run by
- National Cancer Institute (NCI)
- People needed
- 54
- Starts
- 2005-07-01
- Last updated by the study team
- 2013-09-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
Where it is running
- Roswell Park Cancer Institute — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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