Clinical trial NCT00381862: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Nausea and Vomiting
Keywords: nausea and vomiting
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-09-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
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.
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy
timeFrame: Duration of time that the patient is on study
measure: Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population.
timeFrame: Duration of time the patient is on study
measure: 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.
timeFrame: Duration of time patient is on study
measure: Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy
timeFrame: within 5 days of chemotherapy
Other outcomes:
Locations:
city: Savannah
country: United States
facility: St. Josephs/Cander Hospital
state: Georgia
city: Hilo
country: United States
facility: Kaiser Permanente
state: Hawaii
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Kansas City
country: United States
facility: Kansas City Cancer Center
state: Missouri
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Temple
country: United States
facility: Texas A & M university / Scott and White Clinic
state: Texas
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Joseph Bubalo, PharmD, BCPS, BCOP
role: STUDY_CHAIR
References: