NCT00851045

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2009

Geographic Reach
3 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 12, 2015

Status Verified

September 1, 2015

Enrollment Period

1.9 years

First QC Date

February 23, 2009

Last Update Submit

September 23, 2015

Conditions

Colorectal Cancer (CRC)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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

Drug: IrinotecanDrug: 5-Fluorouracil (bolus)Drug: 5-Fluorouracil (infusional)Drug: Leucovorin calciumDrug: CT-322

Arm 2

ACTIVE COMPARATOR

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

Drug: IrinotecanDrug: 5-Fluorouracil (bolus)Drug: 5-Fluorouracil (infusional)Drug: Leucovorin calciumDrug: BevacizumabDrug: Bevacizumab Placebo (saline solution)

Interventions

IrinotecanDRUG

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

Also known as: Camptosar
Arm 1Arm 2
5-Fluorouracil (bolus)DRUG

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

Arm 1Arm 2
5-Fluorouracil (infusional)DRUG

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

Arm 1Arm 2
Leucovorin calciumDRUG

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

Arm 1Arm 2
CT-322DRUG

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

Also known as: BMS-844203
Arm 1
BevacizumabDRUG

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

Also known as: Avastin
Arm 2
Bevacizumab Placebo (saline solution)DRUG

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

Also known as: Saline Solution
Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Acrc/Arizona Clinical Research Center, Inc.

Tucson, Arizona, 85715, United States

Location

Compassionate Cancer Care Medical Group Inc

Fountain Valley, California, 92708, United States

Location

Compassionate Cancer Care Medical Group, Inc

Riverside, California, 92501, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

Midwest Center For Hematology/Oncology

Joliet, Illinois, 60432, United States

Location

Cancer Center Of Kansas

Wichita, Kansas, 67214, United States

Location

Gurtler, Jayne

Metairie, Louisiana, 70006, United States

Location

Guthrie Clinic, Ltd

Sayre, Pennsylvania, 18840, United States

Location

Pharma Resource

East Providence, Rhode Island, 02915, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

University Of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Local Institution

Bahía Blanca, Buenos Aires, 8000, Argentina

Location

Local Institution

Capital Federal, Buenos Aires, 1426, Argentina

Location

Local Institution

Terni, 05100, Italy

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

IrinotecanFluorouracilLeucovorinCT-322BevacizumabSaline Solution

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 25, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

October 12, 2015

Record last verified: 2015-09

Locations

US(12)IT(1)AR(2)