Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX
- Conditions
- Colorectal CancerNausea and Vomiting
- Interventions
- Registration Number
- NCT00381862
- Lead Sponsor
- OHSU Knight Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Aprepitant and Palonosetron palonosetron hydrochloride - Aprepitant and Palonosetron quality-of-life assessment - Aprepitant and Palonosetron leucovorin calcium - Aprepitant and Palonosetron fluorouracil - Aprepitant and Palonosetron dexamethasone - Aprepitant and Palonosetron aprepitant - Aprepitant and Palonosetron oxaliplatin - Aprepitant and Palonosetron irinotecan hydrochloride -
- Primary Outcome Measures
Name Time Method Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy. Up to 24 weeks
- Secondary Outcome Measures
Name Time Method Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy Duration of time that the patient is on study 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. Duration of time patient is on study Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy within 5 days of chemotherapy Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population. Duration of time the patient is on study
Trial Locations
- Locations (6)
St. Josephs/Cander Hospital
🇺🇸Savannah, Georgia, United States
Kaiser Permanente
🇺🇸Hilo, Hawaii, United States
OHSU Knight Cancer Institute
🇺🇸Portland, Oregon, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Kansas City Cancer Center
🇺🇸Kansas City, Missouri, United States
Texas A & M university / Scott and White Clinic
🇺🇸Temple, Texas, United States