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

NCT00381862 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000503649OHSU-SOL-06006-LMOHSU-IRB-2302
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 6

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.

Conditions

Colorectal Cancer; Nausea and Vomiting

Keywords

nausea and vomiting; recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (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.

  Up to 24 weeks

Secondary Outcomes (4)

• Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy

  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.

  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.

  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

  within 5 days of chemotherapy

Study Arms (1)

Aprepitant and Palonosetron

EXPERIMENTAL

Drug: aprepitant; Drug: dexamethasone; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: oxaliplatin; Drug: palonosetron hydrochloride; Procedure: quality-of-life assessment

Interventions

aprepitant DRUG

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

Also known as: Emend, MK-869, L-758,298, L-754,030

Aprepitant and Palonosetron

dexamethasone DRUG

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

Aprepitant and Palonosetron

fluorouracil DRUG

as per institutional standard of care

Also known as: 5-FU

Aprepitant and Palonosetron

irinotecan hydrochloride DRUG

as per institutional standard of care

Also known as: Trade names: Camptosar®, Other names: Camptothecin-11, CPT-11

Aprepitant and Palonosetron

leucovorin calcium DRUG

as per institutional standard of care

Also known as: Generic Name: Leucovorin, Other Names: Citrovorum Factor, Folinic Acid

Aprepitant and Palonosetron

oxaliplatin DRUG

as per institutional standard of care

Also known as: Trade Name: Eloxatin

Aprepitant and Palonosetron

palonosetron hydrochloride DRUG

Palonosetron 0.25 mg IV push on day 1 only.

Also known as: Aloxi

Aprepitant and Palonosetron

quality-of-life assessment PROCEDURE

baseline

Aprepitant and Palonosetron

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

St. Josephs/Cander Hospital

Savannah, Georgia, 31405, United States

Location

Kaiser Permanente

Hilo, Hawaii, 86720, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Kansas City Cancer Center

Kansas City, Missouri, 64104, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

Texas A & M university / Scott and White Clinic

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Nausea; Vomiting; Colonic Neoplasms; Rectal Neoplasms

Interventions

Aprepitant; L 758298; Dexamethasone; Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin; Palonosetron

Condition Hierarchy (Ancestors)

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Uracil; Pyrimidinones; Pyrimidines; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines

Results Point of Contact

• Title: Joseph Bubalo, PharmD, BCPS, BCOP
• Organization: OHSU Knight Cancer Institute

bubaloj@ohsu.edu

503-494-1080

Study Officials

• Joseph Bubalo, PharmD, BCPS, BCOP

  OHSU Knight Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 28, 2006
• Study Start: June 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 12, 2017
• Results First Posted: August 10, 2011

Record last verified: 2017-05

Locations

US (6)