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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00560560
First received: November 15, 2007
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Colorectal Neoplasm
Biological: CP-751, 871
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Single Arm Study Of CP-751,871 In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Estimate of the 6 Month Survival Probability [ Time Frame: Baseline up to Month 6 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From date of enrollment until death or censorship, up to 33 months ] [ Designated as safety issue: No ]
    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.

  • Progression-Free Survival (PFS) [ 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. ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Objective Response [ 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 ] [ Designated as safety issue: No ]
    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.

  • Descriptive Summary of Figitumumab Concentration Versus Time [ Time Frame: Pre-dose on Day 1, 1 hour after end of infusion (post-dose) on Day 2 in Cycle 1, pre-dose on Day 1 in Cycles 2,3,4, 1 hour post-dose on Day 1 in Cycle 5 ] [ Designated as safety issue: No ]
    The measurement of mean plasma concentration of figitumumab in Day 1 of Cycle 1,2,3,4,5

  • Participants Reporting Positive for Total Anti-drug Antibodies (ADA) [ Time Frame: Up to 2 hours prior to infusion in Cycles 1 and 4, at the end of treatment, and at the 4th scheduled follow-up visit (~150 days after the last infusion) ] [ Designated as safety issue: Yes ]
    The immunogenicity of figitumumab in terms of producing an antidrug antibody (ADA) response were monitored.

  • Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R) [ Time Frame: Cycle 1 pre-dosing and Cycle 4 pre-dosing ] [ Designated as safety issue: No ]
    The quantification of circulating tumor cells (CTCs) expressing the IGF-1R in this patient population. Blood samples were collected, and were measured using an automated microscope system.

  • Counts of Circulating Tumor Cells (CTCs) [ Time Frame: Cycle 1 pre-dosing and Cycle 4 pre-dosing ] [ Designated as safety issue: No ]
    The quantification of circulating tumor cells (CTCs)in this patient population. Blood samples were collected, and were measured using an automated microscope system.


Enrollment: 168
Study Start Date: December 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Single arm study
Biological: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560560

Locations
United States, California
Pfizer Investigational Site
San Francisco, California, United States, 94115
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Spain
Pfizer Investigational Site
Elche, Alicante, Spain, 03202
Pfizer Investigational Site
L'hospitalet de Llobregat, Barcelona, Spain, 08907
Pfizer Investigational Site
Barcelona, Spain, 08003
Pfizer Investigational Site
Sevilla, Spain, 41013
United Kingdom
Pfizer Investigational Site
Peterborough, Cambridgeshire, United Kingdom, PE3 6DA
Pfizer Investigational Site
Leicester, Leicestershire, United Kingdom, LE1 5WW
Pfizer Investigational Site
Cardiff, United Kingdom, CF14 2TL
Pfizer Investigational Site
Glasgow, United Kingdom, G12 0YN
Pfizer Investigational Site
Peterborough, United Kingdom, PE3 6DA
Pfizer Investigational Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00560560     History of Changes
Other Study ID Numbers: A4021006
Study First Received: November 15, 2007
Results First Received: January 18, 2013
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Refractory Colorectal
Single arm
Phase 2

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 29, 2014