Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX
Condition: Colorectal Cancer; Nausea and Vomiting
MeSH terms: Colorectal Neoplasms; Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the efficacy, in terms of nausea and vomiting control, of aprepitant,
           palonosetron hydrochloride, and dexamethasone, in preventing chemotherapy-induced nausea
           and vomiting in patients receiving FOLFOX or FOLFIRI chemotherapy for metastatic
           colorectal cancer.

      Secondary

        -  Assess the percentage of patients with no emesis and no rescue therapy when treated with
           aprepitant, palonosetron hydrochloride, and dexamethasone during repeated courses of
           FOLFOX or FOLFIRI chemotherapy.

        -  Assess the effects of aprepitant on nausea, appetite, taste changes (via visual analogue
           scale), nutritional intake, and mucositis in these patients.

        -  Assess the safety of this regimen in these patients.

      OUTLINE: This is an open-label, multicenter study.

      Beginning 1 hour prior to the initiation of chemotherapy on day 1, patients receive oral
      aprepitant on days 1-3, oral dexamethasone on days 1-4, and palonosetron hydrochloride IV on
      day 1.

      Nausea is assessed daily for up to 4 courses of chemotherapy.

      Quality of life is assessed at baseline.

      PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
    

Intervention name(s): aprepitant; dexamethasone; fluorouracil; irinotecan hydrochloride; leucovorin calcium; oxaliplatin; palonosetron hydrochloride; quality-of-life assessment
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): 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
Other intervention name(s): Emend; MK-869; L-758,298; L-754,030; 5-FU; Trade names: Camptosar®; Other names: Camptothecin-11, CPT-11; Generic Name: Leucovorin; Other Names: Citrovorum Factor, Folinic Acid; Trade Name: Eloxatin; Aloxi
Intervention MeSH terms: Leucovorin; Dexamethasone; Fluorouracil; Oxaliplatin; Irinotecan; Camptothecin; Aprepitant; Palonosetron; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: nausea and vomiting; recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer