Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-09-30

Brief Summary

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This study will test if there is any survival benefit in patients with refractory metastatic colorectal cancer that receive CP-751, 871.

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Detailed Description

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Conditions

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Colorectal Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Single arm study

Group Type EXPERIMENTAL

CP-751, 871

Intervention Type BIOLOGICAL

Human IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops.

Interventions

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CP-751, 871

Human IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients who have stage IV colorectal cancer
* Patients whose disease has worsened despite prior anti-cancer therapy
* Patients who have satisfactory bonemarrow, kidney and liver function

Exclusion Criteria

* Patients who are being simultaneously treated with another anti-cancer therapy.
* Patients who have previously received anti-cancer therapy that works like CP-751, 871 (targets insulin-like growth factor receptor)
* Patients that are pregnant or breast-feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No