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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

Study Description
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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.


Condition or disease Intervention/treatment 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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : June 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Aprepitant and Palonosetron 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381862


Locations
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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
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Study Chair: Joseph Bubalo, PharmD, BCPS, BCOP OHSU Knight Cancer Institute
More Information
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Responsible Party: Joseph Bubalo, PharmD, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00381862    
Other Study ID Numbers: CDR0000503649
OHSU-SOL-06006-LM ( Other Identifier: OHSU Knight Cancer Institute )
OHSU-IRB-2302 ( Other Identifier: OHSU IRB )
First Posted: September 28, 2006    Key Record Dates
Results First Posted: August 10, 2011
Last Update Posted: June 12, 2017
Last Verified: May 2017
Keywords provided by Joseph Bubalo, 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:
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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
Leucovorin
 Dexamethasone
Fluorouracil
Oxaliplatin
Irinotecan
Camptothecin
Aprepitant
Palonosetron
Levoleucovorin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids