Trials Sponsors Conditions Drugs Pricing

Conditions

Colorectal Cancer Nausea and Vomiting

Keywords

nausea and vomitingrecurrent colon cancerstage IV colon cancerrecurrent rectal cancerstage 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: aprepitantDrug: dexamethasoneDrug: fluorouracilDrug: irinotecan hydrochlorideDrug: leucovorin calciumDrug: oxaliplatinDrug: palonosetron hydrochlorideProcedure: quality-of-life assessment

Interventions

aprepitantDrug

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

dexamethasoneDrug

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

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHcollaborator
OHSU Knight Cancer Institute
Otherlead

Study Sites (6)

St. Josephs/Cander Hospital

Savannah, Georgia, 31405, United States

Kaiser Permanente

Hilo, Hawaii, 86720, United States

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Kansas City Cancer Center

Kansas City, Missouri, 64104, United States

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Texas A & M university / Scott and White Clinic

Temple, Texas, 76508, United States

MeSH Terms

Conditions

Colorectal NeoplasmsNauseaVomitingColonic NeoplasmsRectal Neoplasms

Interventions

AprepitantL 758298DexamethasoneFluorouracilIrinotecanLeucovorinOxaliplatinPalonosetron

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal Neoplasms

Results Point of Contact

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

Study Officials

Joseph Bubalo, PharmD, BCPS, BCOP
OHSU Knight Cancer Institute
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

54 participants (actual enrollment reported by the registry).

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 2006

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Aprepitant and Palonosetron

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Aprepitant and Palonosetron

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations