Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00052559
Phase
PHASE1
Status
Completed

Conditions

  • Adenocarcinoma of the Rectum
  • Stage II Rectal Cancer
  • Stage III Rectal Cancer

Eligibility Criteria

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

Interventions

  • bevacizumab — BIOLOGICAL
    Given IV
  • fluorouracil — DRUG
    Given IV
  • external beam radiation therapy — RADIATION
    Undergo external beam radiation therapy
  • therapeutic conventional surgery — PROCEDURE
    Undergo surgery
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase I trial is studying the side effects and best dose of bevacizumab when given together with fluorouracil and external-beam radiation therapy in treating patients with stage II or stage III rectal cancer. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining monoclonal antibody therapy with chemotherapy and radiation therapy may kill more tumor cells.

Key Dates

First listed
Jan 27, 2003
Start date
Aug 31, 2002
Status verified
Jun 2013
Primary completion
Apr 30, 2003

Study Design

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

Arms

  • Experimental: Treatment (bevacizumab, fluorouracil, radiation therapy)
    Patients receive bevacizumab IV over 30-90 minutes on day 1 (courses 1-4). Beginning with course 2, patients also receive fluorouracil IV continuously on days 1-14 and undergo external beam radiotherapy on days 1-5 and 8-12. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo surgery 7 weeks after completion of chemoradiotherapy. Cohorts of 6 patients receive escalating doses of bevacizumab until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 20 additional patients are treated at the MTD.

Primary Outcome Measure

Maximum tolerated dose of bevacizumab when administered concurrently with 5-fluorouracil (5-FU) and external beam radiation therapy (EBRT) in patients with cT3 and T4 rectal cancer prior to surgery [ Time Frame: 29 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital Cancer Center· Boston, MADuke University Medical Center· Durham, NC

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