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

Pfizer168 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

168

Conditions

Colorectal Neoplasm

Interventions

CP-751, 871BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Pfizer Investigational Site

San Francisco, California, United States

Pfizer Investigational Site

Dallas, Texas, United States

Pfizer Investigational Site

Elche, Alicante, Spain

Outcomes

Primary Outcomes

Estimate of the 6 Month Survival Probability

The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.

Time frame: Baseline up to Month 6

Secondary Outcomes

Overall Survival

The time from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.

Time frame: From date of enrollment until death or censorship, up to 33 months

Progression-Free Survival (PFS)

The period from study entry until disease progression. Participants without progression or death were censored at time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of longest diameters of target measurable lesions, or a clear increase in a non-target lesion, or the apprearance of new lesions.

Time frame: Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up.

Percentage of Participants With Objective Response

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease. PR applied only to participants with at least one measurable lesion. Greater than or equal to 30 % decrease under baseline of the sum of longest diameters of all target measurable lesions.

Time frame: Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months

Data from ClinicalTrials.gov

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