Phase 2
Completed N=54
Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX
Source: ClinicalTrials.gov NCT00381862 ↗Enrolled (actual)
54
Serious AEs
53.7%
Results posted
Aug 2011
Primary outcomePrimary: 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
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.
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 |
— | — |
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
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. Informational only — not medical advice.