Arsenic Trioxide, Fluorouracil, and Leucovorin in Treating Patients With Stage IV Colorectal Cancer That Has Relapsed or Not Responded to Treatment

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed colorectal cancer
• •Stage IV disease (i.e., any T, any N, M1 disease)
• •Relapsed or refractory disease
• •* Disease progressed after ≥ 2 different fluorouracil-containing chemotherapy regimens (e.g., irinotecan hydrochloride or oxaliplatin with or without bevacizumab)
• •Bidimensionally measurable disease
• •Must have tumor amenable to biopsy and be willing to undergo fine-needle aspiration
• •No CNS metastases
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •Life expectancy \> 2 months
• •Platelet count \> 100,000/mm\^3
• •WBC ≥ 3,000/mm\^3
• •Creatinine ≤ 1.5 times upper limit of normal
• •Bilirubin ≤ 2 times normal
• •SGOT ≤ 5 times normal
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for at least 4 months after completion of study treatment
• •No preexisting peripheral neuropathy ≥ grade 2
• •Ejection fraction ≥ 30%
• •Baseline QT interval \< 500 msec
• •No serious underlying medical illness or active infection
• •No underlying medical condition that could be aggravated by the treatment
• •No life-threatening disease unrelated to colorectal cancer
• •No other malignancy within the past 5 years unless currently disease-free and all therapy for the malignancy has been completed
• •No preexisting neurological disorder (i.e., seizure disorder) ≥ grade 3
• •No cardiac disease, including any of the following:
• •* Recurrent supraventricular arrhythmia
• •* Any type of sustained ventricular arrhythmia or conduction block (e.g., grade II or III atrioventricular block or left bundle branch block)
• •* Uncontrolled ischemic heart disease
• •* History of nonsustained ventricular tachycardia
• •* Prolonged PR intervals (i.e., 1st degree heart block)
• •No known hypersensitivity to arsenic trioxide or fluorouracil
• •No history of allergic reactions attributed to compounds of similar biologic composition to arsenic trioxide or fluorouracil
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Recovered from all treatment-related toxicity
• •At least 4 weeks since prior chemotherapy or radiotherapy and recovered
• •More than 4 weeks since prior investigational drug
• •No other concurrent investigational or commercial anticancer agent or therapy
• •Concurrent local radiotherapy allowed for symptom relief (e.g., significant onset of pain after enrollment, but before beginning study therapy)