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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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00381862
First received: September 26, 2006
Last updated: December 12, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Nausea and Vomiting
 Drug: aprepitant
Drug: dexamethasone
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin
Drug: palonosetron hydrochloride
Procedure: quality-of-life assessment
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 54
Study Start Date: June 2006
Study Completion Date: July 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381862

Locations
United States, Georgia
St. Josephs/Cander Hospital
Savannah, Georgia, United States, 31405
United States, Hawaii
Kaiser Permanente
Hilo, Hawaii, United States, 86720
United States, Illinois
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Missouri
Kansas City Cancer Center
Kansas City, Missouri, United States, 64104
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
United States, Texas
Texas A & M university / Scott and White Clinic
Temple, Texas, United States, 76508
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Joseph Bubalo, PharmD, BCPS, BCOP OHSU Knight Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00381862     History of Changes
Other Study ID Numbers: CDR0000503649, OHSU-SOL-06006-LM, OHSU-IRB-2302
Study First Received: September 26, 2006
Results First Received: June 10, 2011
Last Updated: December 12, 2011
Health Authority: United States: Federal Government

Keywords provided by OHSU Knight Cancer Institute:
nausea and vomiting
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Nausea
Vomiting
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
 Camptothecin
Irinotecan
Oxaliplatin
Dexamethasone
Fluorouracil
BB 1101
Dexamethasone acetate
Aprepitant
Dexamethasone 21-phosphate
Leucovorin
Levoleucovorin
Palonosetron
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013