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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer (CRC)

Treatments: Drug: 5-Fluorouracil (bolus); Drug: Irinotecan; Drug: Bevacizumab; Drug: 5-Fluorouracil (infusional); Drug: Leucovorin calcium; Drug: CT-322; Drug: Bevacizumab Placebo (saline solution)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00851045

EUDRACT # 2008-006561-89

CA196-004

Details and patient eligibility

About

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

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups

Arm 1

Active Comparator group

Description:

Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322

Treatment:

Drug: CT-322

Drug: Leucovorin calcium

Drug: 5-Fluorouracil (infusional)

Drug: Irinotecan

Drug: 5-Fluorouracil (bolus)

Arm 2

Active Comparator group

Description:

Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)

Treatment:

Drug: Bevacizumab Placebo (saline solution)

Drug: Leucovorin calcium

Drug: 5-Fluorouracil (infusional)

Drug: Bevacizumab

Drug: Irinotecan

Drug: 5-Fluorouracil (bolus)