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Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy

A Phase 2 Study of Irinotecan and Cetuximab on an Every 2 Week Schedule, as Second Line Therapy in Patients With Advanced Colorectal Cancer

NCT00336856•University of Pittsburgh

View on ClinicalTrials.gov

Summary

Research Hypothesis: Subjects in the study population who are treated with cetuximab in combination with irinotecan will have higher response rates than subjects treated with irinotecan alone.

Detailed Description

Primary Objective: ·The primary aim of this study is to assess the response rate of patients with previously treated colorectal cancer (CRC) Number of Subjects: 31 Study Population: Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC. Test Product, Dose and Mode of Administration, Duration of Treatment: Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes. Reference Therapy, Dose and Mode of Administration, Duration of Treatment: Irinotecan administered at a dose of 150a or 180 mg/m2 IV over 60 minutes every two weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must consent to be in the study
•Patients must have advanced, surgically unresectable CRC, who have failed a first line metastatic regimen, within 12 months of starting protocol therapy.
•Patients must have measurable disease
•There must be histologic confirmation of adenocarcinoma of the colon or rectum.
•Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
•Estimated life expectancy of at least 12 weeks.
•One prior therapy for metastatic disease is permitted.
•Recurrence within 12 months of adjuvant therapy with FOLFOX or a similar regimen (i.e FLOX, CapOX) is considered one regimen and allowed for study
•There must be evidence of adequate organ function
•Age \> 18 yrs.

Exclusion Criteria

•Any prior therapy with irinotecan or cetuximab or an EGFR targeting agent.
•Any systemic therapy administered for metastatic or locally recurrent colorectal cancer within 28 days of study treatment.
•Patients who are considered candidates for surgical resection of metastatic and/or locally advanced disease.
•Any histology other than adenocarcinoma of the colon or rectum.
•Serious concomitant medical conditions that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
•Evidence of central nervous system metastases
•Pulmonary fibrosis or interstitial pneumonitis
•General Medical Concerns
•History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
•Serious, uncontrolled, concurrent infection.
+9 more criteria

Locations (1)

UPMC Cancer Centers

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

June 1, 2006

Primary Completion Date

June 1, 2011

Completion Date

June 1, 2011

Last Updated

July 12, 2016

Enrollment

ACTUAL participants

Conditions

Colon CancerRectum Cancer

Interventions

Cetuximab

DRUG

Irinotecan

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy

Inclusion Criteria

Exclusion Criteria

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