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Completed

NCT Number: NCT00851045

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

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

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Key information

Conditions

Colorectal Cancer (CRC) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Bahía Blanca, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irinotecan

Drug

Solution, IV, 180 mg/m2, Q14 days, Until PD

Other names: Camptosar

5-Fluorouracil (bolus)

Drug

Solution, IV, 400 mg/m2, Q14 days, Until PD

5-Fluorouracil (infusional)

Drug

Solution, IV, 2400 mg/m2, Q14 days, Until PD

leucovorin calcium

Drug

Solution, IV, 400 mg/m2, Q14 days, Until PD

CT-322

Drug

Solution, IV, 2 mg/kg, Q7 days, Until PD

Other names: BMS-844203

Bevacizumab

Drug

Solutions, IV, 5 mg/kg, Q14 days, Until PD

Other names: Avastin

Bevacizumab Placebo (saline solution)

Drug

Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD

Other names: Saline Solution

Primary outcomes

  1. Progression free survival based on tumor assessments (CT/MRI)

    Time frame: Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent

Secondary outcomes

  1. Overall survival (OS), defined as the time the subject is randomized until death, in each arm

    Time frame: every 12 weeks

  2. 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

    Time frame: every 6 weeks

  3. 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

    Time frame: weekly

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Double-Blind, Phase II Trial of CT-322 (BMS-844203) Plus Irinotecan, 5-FU and Leucovorin (FOLFIRI) Versus Bevacizumab Plus FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 25, 2009
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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