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

Inclusion Criteria

• •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