Clinical trial NCT00381862 (phase 2, status: completed)
Conditions: colorectal cancer, nausea and vomiting
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, R11.10, R11.12, R11.14, R11.11, K91.0, O21.2, O21.8
Drugs: aprepitant, dexamethasone, fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin, palonosetron hydrochloride
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12, NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@]12CCCC3=C1C(=CC=C3)C(=O)N(C2)[C@@H]1CN2CCC1CC2
Eligibility 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