Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer

Phase 2

Completed

• Conditions: Colorectal Cancer (CRC)
• Interventions: Drug: Irinotecan; Drug: 5-Fluorouracil (bolus); Drug: 5-Fluorouracil (infusional); Drug: Leucovorin calcium; Drug: CT-322; Drug: Bevacizumab; Drug: Bevacizumab Placebo (saline solution)

• Registration Number: NCT00851045
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-23
• Study First Posted: 2009-02-25
• Study Start: 2009-10
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• ECOG Performance Status (PS) ≤1
• Histologically or cytologically confirmed, unresectable metastatic colorectal cancer
• Measurable disease by RECIST guidelines
• Evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)
• Available paraffin embedded tumor tissue
• Willing to give a whole blood sample for the study of proteins and genetic polymorphisms

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Exclusion Criteria

• Less than 28 days elapsed since major surgery at time of randomization
• Known CNS metastases
• Excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident
• Uncontrolled hypertension
• Clinically significant cardiovascular disease
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
• Known HIV Positive

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	5-Fluorouracil (infusional)	Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
Arm 1	5-Fluorouracil (infusional)	Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
Arm 2	Irinotecan	Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
Arm 2	Bevacizumab Placebo (saline solution)	Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
Arm 1	Leucovorin calcium	Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
Arm 1	Irinotecan	Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
Arm 1	5-Fluorouracil (bolus)	Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
Arm 2	Leucovorin calcium	Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
Arm 1	CT-322	Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
Arm 2	5-Fluorouracil (bolus)	Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
Arm 2	Bevacizumab	Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)

Primary Outcome Measures

Name	Time	Method
Progression free survival based on tumor assessments (CT/MRI)	Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS), defined as the time the subject is randomized until death, in each arm	every 12 weeks
Objective tumor response rate (ORR), defined as the proportion of randomized subjects in each arm whose best response is CR (complete response) or PR (partial response) using RECIST guidelines as determined by the site investigator	every 6 weeks
Safety in the CT-322 plus irinotecan, 5-FU and leucovorin arm as measured by incidence of serious and non-serious adverse events, significant laboratory evaluations and significant physical examination findings in subjects	weekly

Trial Locations

Locations (13)

Midwest Center For Hematology/Oncology; 🇺🇸 Joliet, Illinois, United States

Pharma Resource; 🇺🇸 East Providence, Rhode Island, United States

Compassionate Cancer Care Medical Group Inc; 🇺🇸 Fountain Valley, California, United States

Compassionate Cancer Care Medical Group, Inc; 🇺🇸 Riverside, California, United States

University Of Texas M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Sharp Memorial Hospital; 🇺🇸 San Diego, California, United States

Guthrie Clinic, Ltd; 🇺🇸 Sayre, Pennsylvania, United States

Acrc/Arizona Clinical Research Center, Inc.; 🇺🇸 Tucson, Arizona, United States

Florida Cancer Specialists; 🇺🇸 Fort Myers, Florida, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Gurtler, Jayne; 🇺🇸 Metairie, Louisiana, United States

Cancer Center Of Kansas; 🇺🇸 Wichita, Kansas, United States

Local Institution; 🇮🇹 Terni, Italy