Clinical trial NCT01367275
Conditions: Colorectal Cancer Colorectal Adenocarcinoma
Keywords: colon Colorectum Colorectal Cancer Plasma FGF Colorectal adenocarcinoma Bevacizumab Brivanib BMS-582664 Irinotecan CPT-11 Camptosar Fibroblast Growth Factor bFGF tyrosine kinase receptors vascular endothelial growth factor receptors VEGFR fibroblast growth factor receptors FGFR
Sponsor: M.D. Anderson Cancer Center
Start date: 2011-08-01; Completion date: 2013-11-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if adding brivanib to irinotecan can help control the disease in patients with colorectal cancer that has spread. The safety of this drug combination will also be studied.

Detailed description:
Study Drugs:

Brivanib is designed to keep cancer cells from receiving the blood supply they need. This may slow down the growth of cancer cells.

Irinotecan is designed to interfere with the DNA (genetic material) of cancer cells. This may slow down the growth and spread of cancer cells.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take brivanib by mouth 1 time every day. The study drug should be taken at the same time each day with a glass (about 8 ounces) of water. You can take it with or without food.

You will be given irinotecan by vein over about 1½ hours on Day 1 of each 14-day cycle. You may be given other drugs to help prevent side effects. The study staff will tell you about these drugs, how they will be given, and the possible risks.

If you have a side effect, you should tell your doctor or study nurse right away. Your study doctor may prescribe drugs for your side effects, delay future treatments, lower the dose of the study drugs, or stop your treatment with the study drugs.

Study Visits:

On Day 7 of Cycle 1:

* Your vital signs will be measured.
* Blood (about 2 tablespoons) will be drawn for routine tests and to check your thyroid function. If the doctor thinks it is needed, part of the blood may be used to check your blood's ability to clot.

Before all cycles, starting with Cycle 2:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* Blood (about 1-2 tablespoons) will be collected for routine tests. If the doctor thinks it is needed, part of the blood may be used to check your blood's ability to clot if needed.
* You will be asked about any drugs you may have taken and side effects you may have had.
* Before Cycles 2 and 3 only, blood (about 1 tablespoon) will be drawn to check your thyroid function.

Every 8 weeks:

* You will have a CT scan or MRI scan to check the status of the disease.
* Blood (about 2-3 tablespoons) will be drawn for thyroid, CEA, and cytokine testing.
* Urine will be collected for routine tests.

Every 12 weeks (Weeks 12, 24, 36, and so on), you will have an ECHO to check your heart function.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.

End-of-Treatment Visit:

Within 2 weeks after you stop taking the study drugs, the following tests and procedures will be performed if not done in the last 14 days:

* You will be asked about any side effects you may have had and any drugs you may be taking.
* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* You will have a CT scan or MRI scan to check the status of the disease.
* Blood (about 1-2 tablespoons) and urine will be collected for routine tests.
* Blood (about 2-3 tablespoons) will be drawn for thyroid, CEA, and cytokine testing.

Long-Term Follow-Up:

After you stop taking the study drugs, you will be called every 3 months. You will be asked questions about your health. These calls should last about 15 minutes each time.

This is an investigational study. Brivanib is not FDA approved or commercially available. It is currently being used for research purposes only. Irinotecan is FDA approved and commercially available for the treatment of colorectal cancer. The combination of brivanib and irinotecan is considered investigational.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Arms: arm 1: Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m\^2 on Day 1.
Interventions: intervention 1: Brivanib intervention 2: Irinotecan
Intervention descriptions: intervention 1: 800 mg (4 x 200 mg tablets) self-administered orally at approximate same time each day on a continuous daily schedule Days 1-14 of 14 day cycle. intervention 2: 180 mg/m\^2 by vein on Day 1 of a 14 day cycle.

Protocol documents: