Phase II Trial Evaluating the Efficacy and Tolerability of Aprepitant & Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting
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.
Nausea and Vomiting
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: palonosetron hydrochloride
Procedure: quality-of-life assessment
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Multi-Center, Open-Label Trial to Evaluate the Efficacy and Tolerability of Aprepitant and Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Colorectal Cancer (CRC) Patients Receiving FOLFOX or FOLFIRI Chemotherapy|
- Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy. [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
- Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy [ Time Frame: Duration of time that the patient is on study ] [ Designated as safety issue: No ]
- Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population. [ Time Frame: Duration of time the patient is on study ] [ Designated as safety issue: No ]
- To Assess the Safety of the Combination of Aprepitant, Palonosetron, and Dexamethasone in the Colorectal Cancer(CRC) Population in the First and Subsequent Cycles of Chemotherapy. [ Time Frame: Duration of time patient is on study ] [ Designated as safety issue: Yes ]
- Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy [ Time Frame: within 5 days of chemotherapy ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||July 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
- Trade names: Camptosar®
- Other names: Camptothecin-11, CPT-11
- Generic Name: Leucovorin
- Other Names: Citrovorum Factor, Folinic Acid
- 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.
- 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.
|United States, Georgia|
|St. Josephs/Cander Hospital|
|Savannah, Georgia, United States, 31405|
|United States, Hawaii|
|Hilo, Hawaii, United States, 86720|
|United States, Illinois|
|Ingalls Memorial Hospital|
|Harvey, Illinois, United States, 60426|
|United States, Missouri|
|Kansas City Cancer Center|
|Kansas City, Missouri, United States, 64104|
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|United States, Texas|
|Texas A & M university / Scott and White Clinic|
|Temple, Texas, United States, 76508|
|Study Chair:||Joseph Bubalo, PharmD, BCPS, BCOP||OHSU Knight Cancer Institute|