A Phase I/II Study of Bevacizumab, Erlotinib and 5-fluorouracil With Concurrent External Beam Radiation Therapy in Locally Advanced Rectal Cancer
- All participants will receive the following drugs: 5-fluorouracil (5-FU) given as a
continuous 24-hour infusion; Bevacizumab given intravenously; erlotinib given orally at
home. In the Phase I portion, we are looking for the highest dose of erlotinib that
can be given safely in combination with the 5-FU, bevacizumab and radiation therapy.
Therefore the dose of erlotinib may not be the same for each participant. The dose
will increase until we find the highest dose without causing serious or unmanageable
- Study treatment is given as an outpatient and consists of 14 day cycles with a total of
3 cycles. Patients will be given all three study drugs and radiation therapy on a
monday (unless a monday falls on on a holiday). This will be day 1 of the first
treatment cycle. 5-FU is given continuously days 1-14. Bevacizumab is given on day 1.
Erlotinib will be given on days 1-14. Radiation therapy will be performed on Days 1-5
- The following tests and procedures will be performed weekly while participants are
receiving study treatment: physical examination, measurement of vital signs, height and
weight; performance status; blood work, urine sample.
- At the end of treatment the following tests will be performed: physical examination and
measurement of vital signs; performance status; blood work; CT scans of chest, abdomen
and pelvis. Patients will also be evaluated for surgery at this time. Patients will be
followed every three months for the first three years after surgery, then every 6
months for the next two years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the dose-limiting toxicity and the maximum tolerated dose of 5-FU, bevacizumab, and erlotinib when administered in combination with external beam radiation therapy
Lawrence S. Blaszkowsky, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|