Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX

DISEASE CHARACTERISTICS:

• Diagnosis of colorectal cancer
• Metastatic disease

• Scheduled to receive 1 of the following chemotherapy regimens*:

  • FOLFOX 4 (oxaliplatin, fluorouracil, leucovorin calcium)
  • FOLFOX 6
  • FOLFOX 7
  • FOLFIRI (irinotecan hydrochloride, fluorouracil, leucovorin calcium) NOTE: *Regimens may also include cetuximab or bevacizumab

• No emesis and no requirement for antiemetic agents within 48 hours prior to beginning chemotherapy

  • Single-agent benzodiazepines as a hypnotic allowed
• No chronic nausea

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy > 4 months
• White Blood Cell(WBC)count > 3,000/mm^³
• Absolute neutrophil count (ANC) > 1,500/mm^³
• Platelet count > 100,000/mm^³
• Bilirubin ≤ 2.5 times upper limit of normal (ULN) (< 5 times ULN if liver metastases present)
• Creatinine ≤ 1.5 times ULN
• Aspartate aminotransferase(AST) or Alanine aminotransferase (ALT) ≤ 2.5 times ULN (< 5 times ULN if liver metastases present)
• Able to swallow tablets and capsules
• No known sensitivity to aprepitant, palonosetron hydrochloride, or dexamethasone
• Not pregnant or nursing
• Negative pregnancy test
• No history of consuming ≥ 5 alcoholic drinks/day within the past year
• No concurrent illness requiring systemic corticosteroids other than planned dexamethasone during study treatment
• No clinical signs of active systemic infection involving the gastrointestinal tract
• No active bowel obstruction

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy > Hesketh level 3

  • Prior fluorouracil with or without leucovorin calcium or capecitabine allowed
• At least 30 days since prior investigational drugs
• At least 14 days since prior neurokinin-1 antagonists
• Concurrent hydrocortisone at physiologic replacement doses (≤ 30 mg/day) allowed
• No concurrent chronic antiemetic agents
• Concurrent hypnotics allowed
• Concurrent rescue antiemetics allowed