5-FU, Aflibercept, and Radiation (RT) for Preoperative and Postoperative Patients With Stage II/III Rectal Cancer

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT01749956
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Radiation — RADIATION
  • Aflibercept — DRUG
  • Surgery — PROCEDURE
    Abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines
  • FOLFOX6 — DRUG

Study Details

The purpose of this Phase II study will be to investigate the antiangiogenic agent, aflibercept, in combination with chemoradiation as preoperative treatment for patients with stage II/III rectal cancer, followed by 4 months of FOLFOX6 plus aflibercept adjuvantly.

Key Dates

Start date
Jan 31, 2013
Status verified
Dec 2016
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FOLFOX6/Aflibercept/Radiation/Surgery
    Preoperative Chemoradiation: (6 weeks) * 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IVCI), Days 1 thru 42; * Radiation: 50.4 Gy (1.8 Gy/day or 28 fractions) Mon thru Fri, Weeks 1 thru 6; * Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15. Surgery at least 6 weeks after last day of aflibercept: Patients will undergo abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines. Postoperative Chemotherapy and Aflibercept Treatments (four 28-day cycles): * Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour (no more than 2 hours) on Days 1 and 15 of each cycle. * Modified FOLFOX6: * Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle. * Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle. * 5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle.

Primary Outcome Measure

Pathologic Complete Response Rate [ Time Frame: Between days 57 and 98 after preoperative chemotherapy ]

Locations (11)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33916-
Woodlands Medical SpecialistsPensacolaFlorida32503-
Florida Cancer SpecialistsSt. PetersburgFlorida33705-
Space Coast Cancer CenterTitusvilleFlorida32796-
Baptist Hospital EastLouisvilleKentucky40207-
Oncology Hematology Care, Inc.CincinnatiOhio45242-
Oklahoma UniversityOklahoma CityOklahoma71304-
South Carolina Oncology AssociatesColumbiaSouth Carolina29210-
Tennessee Oncology - ChattanoogaChattanoogaTennessee37404-
Tennessee Oncology, PLLCNashvilleTennessee37203-
Virginia Cancer InstituteRichmondVirginia23230-

Find similar trials in Fort Myers, FL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Florida Cancer Specialists· Fort Myers, FLWoodlands Medical Specialists· Pensacola, FLFlorida Cancer Specialists· St. Petersburg, FLSpace Coast Cancer Center· Titusville, FLBaptist Hospital East· Louisville, KYOncology Hematology Care, Inc.· Cincinnati, OH

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