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

Primary Purpose

Colorectal Cancer, Nausea and Vomiting

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aprepitant
dexamethasone
fluorouracil
irinotecan hydrochloride
leucovorin calcium
oxaliplatin
palonosetron hydrochloride
quality-of-life assessment
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring nausea and vomiting, recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Josephs/Cander Hospital
  • Kaiser Permanente
  • Ingalls Memorial Hospital
  • Kansas City Cancer Center
  • OHSU Knight Cancer Institute
  • Texas A & M university / Scott and White Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aprepitant and Palonosetron

Arm Description

Outcomes

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.

Secondary Outcome Measures

Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy
Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population.
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.
Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy

Full Information

First Posted
September 26, 2006
Last Updated
May 7, 2017
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00381862
Brief Title
Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX
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 Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Nausea and Vomiting
Keywords
nausea and vomiting, recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aprepitant and Palonosetron
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
aprepitant
Other Intervention Name(s)
Emend, MK-869, L-758,298, L-754,030
Intervention Description
Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
as per institutional standard of care
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Other Intervention Name(s)
Trade names: Camptosar®, Other names: Camptothecin-11, CPT-11
Intervention Description
as per institutional standard of care
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Other Intervention Name(s)
Generic Name: Leucovorin, Other Names: Citrovorum Factor, Folinic Acid
Intervention Description
as per institutional standard of care
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
Trade Name: Eloxatin
Intervention Description
as per institutional standard of care
Intervention Type
Drug
Intervention Name(s)
palonosetron hydrochloride
Other Intervention Name(s)
Aloxi
Intervention Description
Palonosetron 0.25 mg IV push on day 1 only.
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Description
baseline
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Bubalo, PharmD, BCPS, BCOP
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
St. Josephs/Cander Hospital
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Kaiser Permanente
City
Hilo
State/Province
Hawaii
ZIP/Postal Code
86720
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Kansas City Cancer Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64104
Country
United States
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Texas A & M university / Scott and White Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

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

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