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A Phase II Study of 5-Fluorouracil, Bevacizumab (Avastin), and Radiation in the Preoperative or Adjuvant Treatment of Patients With Stage II / III Rectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Rectal Cancer, Cancer of the Rectum, Colorectal Cancer

Thank you

Trial Information

A Phase II Study of 5-Fluorouracil, Bevacizumab (Avastin), and Radiation in the Preoperative or Adjuvant Treatment of Patients With Stage II / III Rectal Cancer


All eligible patients will receive combined modality treatment initially. Systemic treatment
will begin 4-6 weeks after completion of the Combined Modality portion and will complete 4
cycles of a 4 week regimen. Patients with no evidence of disease following systemic therapy
may continue single agent bevacizumab for up to one year. After all treatment is completed,
patients will be re-evaluated with imaging to establish a new baseline. Patients will be
re-evaluated thereafter for up to a total of 5 years.

Combined Modality Treatment:

- bevacizumab 5mg/kg IV infusion days 1, 15, and 29

- fluorouracil 225mg/m2 IV continuous infusion days 1-42

- radiation 1.8 Gy/day or 28 fractions weeks 1-6

Systemic Treatment:

- 5-fluorouracil 400 mg/m2 bolus

- 5-fluorouracil 2400 mg/m2 over 46 hours days 1 and 15

- leucovorin 350 mg prior to FU on days 1 and 15

- oxaliplatin 85 mg/m2 days 1 and 15

- bevacizumab 5 mg/kg days 1 and 15


Inclusion Criteria:



- Histologically confirmed Stage I or II rectal cancer

- Patients must be candidates for preoperative or adjuvant chemoradiation.

- Patients enrolling in the adjuvant chemoradiation cohort must have undergone surgical
resection of the primary rectal tumor between 28 and 56 days (i.e., 4-8 weeks) prior
to study treatment.

- ECOG performance status 0-1

- Adequate bone marrow, liver, and kidney function

- At least 18 years of age

- Able to give written informed consent

Exclusion Criteria:

- Treatment with prior chemotherapy or radiation for rectal cancer

- History of myocardial infarction

- Uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac
arrhythmia requiring medication or peripheral vascular disease

- History of stroke within 6 months

- History of abdominal fistula, gastrointestinal perforation, or intrabdominal abscess
within 6 months

- Symptomatic sensory or peripheral neuropathy

- Prior treatment with anti-angiogenic agents

- Prior malignancy in the past 5 years

- Active infections or serious underlying medical condition

- Major surgery less than 28 days prior

- Women who are pregnant or lactating

- Thrombolytic therapy within 10 days of starting bevacizumab

- PEG tube, G-tube, or external biliary stents

- Proteinuria

- Non healing wound, ulcer or fracture

- History of bleeding diathesis or coagulopathy

- Hemoptysis

- Participation in another experimental trial within 28 days

- Uncontrolled anticoagulant therapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-Free Survival (DFS), The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment

Outcome Description:

The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

David R. Spigel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI GI 65

NCT ID:

NCT00308516

Start Date:

March 2006

Completion Date:

February 2012

Related Keywords:

  • Rectal Cancer
  • Cancer of the Rectum
  • Colorectal Cancer
  • Rectal Cancer
  • Cancer of the Rectum
  • Colorectal Cancer
  • Bevacizumab
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Northeast Arkansas ClinicJonesboro, Arkansas  72401-3125
South Texas Oncology and HematologySan Antonio, Texas  78229
Florida Cancer SpecialistsFort Myers, Florida  33901
Northeast Georgia Medical CenterGainesville, Georgia  30501
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Consultants in Blood Disorders and CancerLouisville, Kentucky  40207
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Peninsula Cancer InstituteNewport News, Virginia  23601
Tennessee OncologyNashville, Tennessee  37203
Wellstar Cancer ResearchMarietta, Georgia  30060
Watson Clinic Center for Cancer Care and ResearchLakeland, Florida  33805
Consultants in Medical Oncology and HematologyDrexel Hill, Pennsylvania  19026
Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee  37404