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

NCT ID: NCT00381862

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-07-31

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.

Conditions

Colorectal Cancer; Nausea and Vomiting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Aprepitant and Palonosetron

Group Type: EXPERIMENTAL

aprepitant

Intervention Type: DRUG

Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle

dexamethasone

Intervention Type: DRUG

Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4

fluorouracil

Intervention Type: DRUG

as per institutional standard of care

irinotecan hydrochloride

Intervention Type: DRUG

as per institutional standard of care

leucovorin calcium

Intervention Type: DRUG

as per institutional standard of care

oxaliplatin

Intervention Type: DRUG

as per institutional standard of care

palonosetron hydrochloride

Intervention Type: DRUG

Palonosetron 0.25 mg IV push on day 1 only.

quality-of-life assessment

Intervention Type: PROCEDURE

baseline

Interventions

aprepitant

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

dexamethasone

Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4

Intervention Type: DRUG

fluorouracil

as per institutional standard of care

Intervention Type: DRUG

irinotecan hydrochloride

as per institutional standard of care

Intervention Type: DRUG

leucovorin calcium

as per institutional standard of care

Intervention Type: DRUG

oxaliplatin

as per institutional standard of care

Intervention Type: DRUG

palonosetron hydrochloride

Palonosetron 0.25 mg IV push on day 1 only.

Intervention Type: DRUG

quality-of-life assessment

baseline

Intervention Type: PROCEDURE

Other Intervention Names

Emend; MK-869; L-758,298; L-754,030; 5-FU; Trade names: Camptosar®; Other names: Camptothecin-11, CPT-11; Generic Name: Leucovorin; Other Names: Citrovorum Factor, Folinic Acid; Trade Name: Eloxatin; Aloxi

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Joseph Bubalo

PharmD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Bubalo, PharmD, BCPS, BCOP

Role: STUDY_CHAIR

OHSU Knight Cancer Institute

Locations

St. Josephs/Cander Hospital

Savannah, Georgia, United States

Kaiser Permanente

Hilo, Hawaii, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Kansas City Cancer Center

Kansas City, Missouri, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

Texas A & M university / Scott and White Clinic

Temple, Texas, United States

Countries

United States

Other Identifiers

OHSU-SOL-06006-LM

Identifier Type: OTHER

Identifier Source: secondary_id

OHSU-IRB-2302

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000503649

Identifier Type: -

Identifier Source: org_study_id