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Trial record 21 of 45 for:    colon cancer | ( Map: Hawaii, United States )

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

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ClinicalTrials.gov Identifier: NCT00381862
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : August 10, 2011
Last Update Posted : June 12, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Joseph Bubalo, OHSU Knight Cancer Institute

Tracking Information
First Submitted Date  ICMJE September 26, 2006
First Posted Date  ICMJE September 28, 2006
Results First Submitted Date  ICMJE June 10, 2011
Results First Posted Date  ICMJE August 10, 2011
Last Update Posted Date June 12, 2017
Study Start Date  ICMJE June 2006
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00381862 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2011)
  • Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy [ Time Frame: Duration of time that the patient is on study ]
  • Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population. [ Time Frame: Duration of time the patient is on study ]
  • 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. [ Time Frame: Duration of time patient is on study ]
  • Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy [ Time Frame: within 5 days of chemotherapy ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX
Official Title  ICMJE 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
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 aprepitant together with palonosetron and dexamethasone works in preventing nausea and vomiting caused by chemotherapy in patients receiving chemotherapy for metastatic colorectal cancer.

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 vomiting in patients receiving FOLFOX or FOLFIRI chemotherapy for metastatic colorectal cancer.

Secondary

  • Assess the percentage of patients with no emesis and no rescue therapy when treated with aprepitant, palonosetron hydrochloride, and dexamethasone during repeated courses of FOLFOX or FOLFIRI chemotherapy.
  • Assess the effects of aprepitant on nausea, appetite, taste changes (via visual analogue scale), nutritional intake, and mucositis in these patients.
  • Assess the safety of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Beginning 1 hour prior to the initiation of chemotherapy on day 1, patients receive oral aprepitant on days 1-3, oral dexamethasone on days 1-4, and palonosetron hydrochloride IV on day 1.

Nausea is assessed daily for up to 4 courses of chemotherapy.

Quality of life is assessed at baseline.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Colorectal Cancer
  • Nausea and Vomiting
Intervention  ICMJE
  • Drug: aprepitant
    Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle
    Other Names:
    • Emend
    • MK-869
    • L-758,298
    • L-754,030
  • Drug: dexamethasone
    Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4
  • Drug: fluorouracil
    as per institutional standard of care
    Other Name: 5-FU
  • Drug: irinotecan hydrochloride
    as per institutional standard of care
    Other Names:
    • Trade names: Camptosar®
    • Other names: Camptothecin-11, CPT-11
  • Drug: leucovorin calcium
    as per institutional standard of care
    Other Names:
    • Generic Name: Leucovorin
    • Other Names: Citrovorum Factor, Folinic Acid
  • Drug: oxaliplatin
    as per institutional standard of care
    Other Name: Trade Name: Eloxatin
  • Drug: palonosetron hydrochloride
    Palonosetron 0.25 mg IV push on day 1 only.
    Other Name: Aloxi
  • Procedure: quality-of-life assessment
    baseline
Study Arms  ICMJE Experimental: Aprepitant and Palonosetron
Interventions:
  • Drug: aprepitant
  • Drug: dexamethasone
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
  • Drug: oxaliplatin
  • Drug: palonosetron hydrochloride
  • Procedure: quality-of-life assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2011)
54
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00381862
Other Study ID Numbers  ICMJE CDR0000503649
OHSU-SOL-06006-LM ( Other Identifier: OHSU Knight Cancer Institute )
OHSU-IRB-2302 ( Other Identifier: OHSU IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph Bubalo, OHSU Knight Cancer Institute
Study Sponsor  ICMJE OHSU Knight Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Joseph Bubalo, PharmD, BCPS, BCOP OHSU Knight Cancer Institute
PRS Account OHSU Knight Cancer Institute
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP