Clinical trial NCT00560560: Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments
Official title: A Phase II, Single Arm Study Of CP-751,871 In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasm
Keywords: Refractory Colorectal
Single arm
Phase 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Estimate of the 6 Month Survival Probability
timeFrame: Baseline up to Month 6
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of enrollment until death or censorship, up to 33 months
measure: Progression-Free Survival (PFS)
timeFrame: 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.
measure: Percentage of Participants With Objective Response
timeFrame: 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
measure: Descriptive Summary of Figitumumab Concentration Versus Time
timeFrame: 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
measure: Participants Reporting Positive for Total Anti-drug Antibodies (ADA)
timeFrame: 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)
measure: Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R)
timeFrame: Cycle 1 pre-dosing and Cycle 4 pre-dosing
measure: Counts of Circulating Tumor Cells (CTCs)
timeFrame: Cycle 1 pre-dosing and Cycle 4 pre-dosing
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Elche
country: Spain
facility: Pfizer Investigational Site
state: Alicante
city: L'hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Peterborough
country: United Kingdom
facility: Pfizer Investigational Site
state: Cambridgeshire
city: Leicester
country: United Kingdom
facility: Pfizer Investigational Site
state: Leicestershire
city: Cardiff
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Peterborough
country: United Kingdom
facility: Pfizer Investigational Site
city: Southampton
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: