AG2037 in Treating Patients With Metastatic Cancer of the Colon or Rectum That Has Not Responded to Fluorouracil and Leucovorin

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum

  • Stage IV or recurrent disease
• Measurable disease

• Disease progression or recurrence during or after completion of prior first-line chemotherapy with fluorouracil and leucovorin calcium (5-FU/LV)

  • Prior irinotecan or oxaliplatin as part of the 5-FU/LV regimen or as subsequent therapy allowed

• Only 2 prior regimens for metastatic disease allowed

  • One additional regimen as adjuvant therapy allowed provided patient remained disease-free for > 6 months after completion of therapy*
  • Newer, targeted investigational agents (e.g., cetuximab or bevacizumab) are not counted as a chemotherapeutic regimen unless used in combination with a cytotoxic regimen NOTE: *If evidence of failure occurred within < 6 months after completion of adjuvant therapy, patients may have received only 1 additional regimen for metastatic disease
• No active brain metastases (requiring treatment or progressing)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 12 weeks

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9 g/dL

Hepatic

• AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver involvement is present)
• Bilirubin ≤ 1.5 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)

Renal

• Creatinine ≤ 1.5 mg/dL
• Creatinine clearance ≥ 60 mL/min

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 1 month after study participation
• No concurrent unstable or severe medical condition that would preclude study participation
• No psychological or sociological condition, addictive disorder, or family problem that would preclude study compliance
• No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix or breast

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• More than 14 days since prior blood transfusion

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy and recovered
• No prior radiotherapy to > 40% of bone marrow space

Surgery

• Not specified

Other

• No prior glycinamide ribonucleotide formyltransferase (GARFT) inhibitors
• More than 28 days since prior investigational agent and recovered
• No concurrent allopurinol