Status:
COMPLETED
Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Nausea and Vomiting
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 apre...
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 vomi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00381862
Start Date
June 1 2006
End Date
July 1 2008
Last Update
June 12 2017
Active Locations (6)
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1
St. Josephs/Cander Hospital
Savannah, Georgia, United States, 31405
2
Kaiser Permanente
Hilo, Hawaii, United States, 86720
3
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
4
Kansas City Cancer Center
Kansas City, Missouri, United States, 64104