Neoadjuvant Chemoradiation With RHUMAB VEGF (Avastin) for Rectal Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00113230
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Avastin (Bevacizumab, RHUMAB VEGF) — DRUG
    Starting Dose 5 mg/kg intravenously on day one of radiotherapy, given every 2 weeks +/- 2 days for a total of 3 doses.
  • Capecitabine — DRUG
    900 mg/m\^2 by mouth twice a day during days of radiation for all five weeks of therapy.
  • Radiation Therapy — RADIATION
    45 Gy in 25 fractions to the pelvis followed by 5.4 Gy as a boost dose to the primary tumor with margin, for a total dose of 50.4 Gy over 28 treatment days.

Study Details

Preoperative chemoradiation leads to increased pelvic control and overall survival, but both distant and local disease control remain problematic in locally advanced rectal cancer patients. Enhancing the effect of chemotherapy and radiotherapy can increase tumor response as well as distant disease control. Patients who have complete response to therapy have increased sphincter preservation, and can possibly have more limited surgery (full thickness local excision). When combined with standard chemotherapy, bevacizumab \[RHUMAB VEGF, Avastin\] has been shown to improve response and median survival in patients with metastatic colorectal cancer in a recent randomized trial, has led to increased activity in preclinical studies with radiotherapy, and has been found to be very well tolerated with chemoradiation in a phase I trial conducted at the M.D. Anderson Cancer Center (MDACC) in patients with locally advanced pancreatic cancer. The hypothesis is that the addition of bevacizumab to standard chemoradiation will safely lead to increased tumor response in patients with locally advanced rectal cancer.

Key Dates

First listed
Jun 7, 2005
Start date
Feb 28, 2005
Status verified
Jul 2012
Primary completion
Jan 31, 2009
Completion
Jan 31, 2009

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Avastin
    Capecitabine, Avastin (RHUMAB VEGF/Bevacizumab) And Radiotherapy

Primary Outcome Measure

Pathologic Local Tumor Response [ Time Frame: Baseline to approximately 5 Months (Following 28 days of treatment, chemotherapy and surgical resection of tumor) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT M. D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
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By specialty
OncologyGI oncology
By research site
UT M. D. Anderson Cancer Center· Houston, TX

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