Conditions: Colorectal Cancer Nausea and Vomiting
Keywords: nausea and vomiting recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 54
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None

Interventions: intervention 1: aprepitant intervention 2: dexamethasone intervention 3: fluorouracil intervention 4: irinotecan hydrochloride intervention 5: leucovorin calcium intervention 6: oxaliplatin intervention 7: palonosetron hydrochloride intervention 8: quality-of-life assessment
Intervention descriptions: intervention 1: Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle intervention 2: Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4 intervention 3: as per institutional standard of care intervention 4: as per institutional standard of care intervention 5: as per institutional standard of care intervention 6: as per institutional standard of care intervention 7: Palonosetron 0.25 mg IV push on day 1 only. intervention 8: baseline

Protocol document: