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Phase II Trial Evaluating the Efficacy and Tolerability of Aprepitant & Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00381862
First received: September 26, 2006
Last updated: July 18, 2013
Last verified: July 2013

September 26, 2006
July 18, 2013
June 2006
March 2008   (final data collection date for 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00381862 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Phase II Trial Evaluating the Efficacy and Tolerability of Aprepitant & Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting
A Multi-Center, Open-Label Trial to Evaluate the Efficacy and Tolerability of Aprepitant and Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Colorectal Cancer (CRC) Patients Receiving FOLFOX or FOLFIRI Chemotherapy

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Colorectal Cancer
  • Nausea and Vomiting
  • 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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
July 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00381862
CDR0000503649, OHSU-SOL-06006-LM, OHSU-IRB-2302
Yes
OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Study Chair: Joseph Bubalo, PharmD, BCPS, BCOP OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
July 2013

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