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

Part of paid clinical trials in Savannah, Georgia.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT00381862
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • aprepitant — DRUG
    Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle
  • dexamethasone — DRUG
    Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4
  • fluorouracil — DRUG
    as per institutional standard of care
  • irinotecan hydrochloride — DRUG
    as per institutional standard of care
  • leucovorin calcium — DRUG
    as per institutional standard of care
  • oxaliplatin — DRUG
    as per institutional standard of care
  • palonosetron hydrochloride — DRUG
    Palonosetron 0.25 mg IV push on day 1 only.
  • quality-of-life assessment — PROCEDURE
    baseline

Study Details

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.

Key Dates

Start date
Jun 30, 2006
Status verified
May 2017
Primary completion
Mar 31, 2008
Completion
Jul 31, 2008

Study Design

Enrollment
54 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Aprepitant and Palonosetron

Primary 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. [ Time Frame: Up to 24 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
St. Josephs/Cander HospitalSavannahGeorgia31405-
Kaiser PermanenteHiloHawaii86720-
Ingalls Memorial HospitalHarveyIllinois60426-
Kansas City Cancer CenterKansas CityMissouri64104-
OHSU Knight Cancer InstitutePortlandOregon97239-3098-
Texas A & M university / Scott and White ClinicTempleTexas76508-

Find similar trials in Savannah, GA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
St. Josephs/Cander Hospital· Savannah, GAKaiser Permanente· Hilo, HIIngalls Memorial Hospital· Harvey, ILKansas City Cancer Center· Kansas City, MOOHSU Knight Cancer Institute· Portland, ORTexas A & M university / Scott and White Clinic· Temple, TX

Related Studies