Phase 2 N=54 Supportive Care

Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX

Colorectal Cancer · Nausea and Vomiting

Bottom Line

View on ClinicalTrials.gov: NCT00381862 ↗

Enrolled (actual)

Serious AEs

53.7%

Results posted

Aug 2011

Primary outcome: Primary: Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy. — 54 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: aprepitant (Drug); dexamethasone (Drug); fluorouracil (Drug); irinotecan hydrochloride (Drug); leucovorin calcium (Drug); oxaliplatin (Drug); palonosetron hydrochloride (Drug); quality-of-life assessment (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: OHSU Knight Cancer Institute
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.	54	—
SECONDARY Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy	—	—
SECONDARY Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population.	—	—
SECONDARY 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.	—	—
SECONDARY Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy	—	—

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.

Eligibility 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) ( 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00381862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.