Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX
Condition: Colorectal Cancer; Nausea and Vomiting
MeSH terms: Colorectal Neoplasms; Nausea; Vomiting
Intervention: aprepitant; dexamethasone; fluorouracil; irinotecan hydrochloride; leucovorin calcium; oxaliplatin; palonosetron hydrochloride; quality-of-life assessment
Intervention description: Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle; Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4; as per institutional standard of care; as per institutional standard of care; as per institutional standard of care; as per institutional standard of care; Palonosetron 0.25 mg IV push on day 1 only.; baseline
Intervention MeSH terms: Leucovorin; Dexamethasone; Fluorouracil; Oxaliplatin; Irinotecan; Camptothecin; Aprepitant; Palonosetron; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: nausea and vomiting; recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer

Summary:

      RATIONALE: Aprepitant, palonosetron, and dexamethasone may help lessen or prevent nausea and
      vomiting in patients receiving chemotherapy.

      PURPOSE: This phase II trial is studying how well giving aprepitant together with
      palonosetron and dexamethasone works in preventing nausea and vomiting caused by chemotherapy
      in patients receiving chemotherapy for metastatic colorectal cancer.
    

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