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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT00851045
Phase
PHASE2
Status
Completed

Conditions

  • Colorectal Cancer (CRC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Solution, IV, 180 mg/m2, Q14 days, Until PD
  • 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
  • Bevacizumab — DRUG
    Solutions, IV, 5 mg/kg, Q14 days, Until PD
  • Bevacizumab Placebo (saline solution) — DRUG
    Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD

Study Details

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

Key Dates

Start date
Oct 31, 2009
Status verified
Sep 2015
Primary completion
Sep 30, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
17 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1
    Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
  • Active Comparator: Arm 2
    Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)

Primary Outcome Measure

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 ]

Locations (12)

FacilityCityStateZIPSite coordinators
Acrc/Arizona Clinical Research Center, Inc.TucsonArizona85715-
Compassionate Cancer Care Medical Group IncFountain ValleyCalifornia92708-
Compassionate Cancer Care Medical Group, IncRiversideCalifornia92501-
Sharp Memorial HospitalSan DiegoCalifornia92123-
Florida Cancer SpecialistsFort MyersFlorida33916-
Midwest Center For Hematology/OncologyJolietIllinois60432-
Cancer Center Of KansasWichitaKansas67214-
Gurtler, JayneMetairieLouisiana70006-
Guthrie Clinic, LtdSayrePennsylvania18840-
Pharma ResourceEast ProvidenceRhode Island02915-
Sarah Cannon Research InstituteNashvilleTennessee37203-
University Of Texas M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Tucson, AZ

By research site
Acrc/Arizona Clinical Research Center, Inc.· Tucson, AZCompassionate Cancer Care Medical Group Inc· Fountain Valley, CACompassionate Cancer Care Medical Group, Inc· Riverside, CASharp Memorial Hospital· San Diego, CAFlorida Cancer Specialists· Fort Myers, FLMidwest Center For Hematology/Oncology· Joliet, IL

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