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
18 Years
N/A
Both
Colorectal Cancer, Nausea and Vomiting
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.
Outcome Time Frame:
Up to 24 weeks
Safety Issue:
No
Principal Investigator
Joseph Bubalo, PharmD, BCPS, BCOP
Investigator Role:
Study Chair
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000503649
NCT ID:
NCT00381862
Start Date:
June 2006
Completion Date:
July 2008
Related Keywords:
- Colorectal Cancer
- Nausea and Vomiting
- nausea and vomiting
- recurrent colon cancer
- stage IV colon cancer
- recurrent rectal cancer
- stage IV rectal cancer
- Colorectal Neoplasms
- Nausea
- Vomiting
Name | Location |
|---|---|
| Ingalls Memorial Hospital | Harvey, Illinois 60426 |
| OHSU Knight Cancer Institute | Portland, Oregon 97239 |
| Kansas City Cancer Center | Kansas City, Missouri 64111 |
| St. Josephs/Cander Hospital | Savannah, Georgia 31405 |
| Kaiser Permanente | Hilo, Hawaii 86720 |
| Texas A & M university / Scott and White Clinic | Temple, Texas 76508 |
