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

OHSU Knight Cancer Institute54 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Colorectal Cancer Nausea and Vomiting

Interventions

aprepitantDRUG

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

dexamethasoneDRUG

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

fluorouracilDRUG

as per institutional standard of care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (6)

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

Outcomes

Primary Outcomes

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 Outcomes

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

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

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

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

Data from ClinicalTrials.gov

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