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) logo

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

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)

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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