Clinical trial · Interventional
Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX
A Multi-Center, Trial to Evaluate the Efficacy & Tolerability of Aprepitant and Palonosetron for the Prevention of CINV in Colorectal Cancer (CRC) Patients Receiving FOLFOX
NCT00381862CI-TRIAL-00028073completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aprepitant | Drug | — | UNRESOLVED |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| palonosetron hydrochloride | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aprepitant and Palonosetron
- interventionNames
- Drug: aprepitant
- Drug: dexamethasone
- Drug: fluorouracil
- Drug: irinotecan hydrochloride
- Drug: leucovorin calcium
- Drug: oxaliplatin
- Drug: palonosetron hydrochloride
- Procedure: quality-of-life assessment
Primary outcomes (1)
- 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.
- timeFrame
- Up to 24 weeks
Secondary outcomes (4)
- measure
- Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.