Clinical trial NCT01730586
Conditions: Colorectal Cancer Cancer of Gastrointestinal Tract
Keywords: Colorectal Cancer Cancer of Gastrointestinal Tract CIMP-high Colorectal Adenocarcinoma Small Bowel Adenocarcinomas Colorectal Small bowel cancer Abraxane Nab-Paclitaxel Paclitaxel (Protein-Bound) ABI-007
Sponsor: M.D. Anderson Cancer Center
Start date: 2012-11-01; Completion date: 2016-08-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if abraxane can help to control colorectal and/or small bowel cancer. The safety of this drug will also be studied.

Abraxane is designed to block cancer cells from dividing, which may cause them to die.

Detailed description:
Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive the study drug in 21-day study cycles.

You will receive abraxane by vein over about 30 minutes on Day 1 of each cycle.

Study Visits:

On Day 1 of all cycles, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your weight and blood pressure.
* You will be asked about any drugs you may be taking and about any symptoms or side effects you may be having.
* Your performance status will be recorded.
* Blood (about 2 tablespoons) will be drawn for routine tests.

At the end of every 3rd cycle (Cycles 3, 6, 9) and so on:

°You will have a CT or MRI scan of your chest, abdomen, and pelvis to check the status of the disease. If at any point the scans show the disease appearing to get better, you will have another scan 2 cycles later.

Length of Treatment:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if you have intolerable side effects, if the study is stopped, or if you are unable to follow study instructions.

Your participation on the study will be over after the follow-up period.

End-of-Treatment Visit:

Within 10 days after you stop taking the study drug, you will have an end-of-treatment visit. At this visit, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your weight and blood pressure.
* You will be asked about any drugs you may be taking and about any symptoms or side effects you may be having.
* Your performance status will be recorded.
* Blood (about 2 tablespoons) will be drawn for routine tests.
* If one has not been performed in the previous 4 weeks, you will have a CT or MRI scan of your chest, abdomen, and pelvis to check the status of the disease.

Follow-Up:

The study staff will ask about any symptoms or side effects you may be having during the 30 days after your last dose of the study drugs. The study staff may ask you by phone or at the time of a routine clinic visit. If the study staff contacts you by phone, the phone call should last about 15-30 minutes.

If you leave the study for any reason other than the disease getting worse, you will have a CT or MRI scan of your chest, abdomen, and pelvis to check the status of the disease every 12 weeks unless you start receiving other treatment.

The study staff will also review your medical records and/or contact you to check the status of the disease every 3 months after you stop receiving the study drug. If you are contacted by phone, each phone call should take about 5 minutes.

This is an investigational study. Abraxane is FDA approved and commercially available for the treatment of breast cancer. It is not FDA approved for the treatment of colorectal or small bowel cancer. The use of abraxane in patients with colorectal cancer or small bowel cancer is investigational.

Up to 35 patients will take part in this study. All will be enrolled at MD Anderson.

Arms: arm 1: Abraxane 220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.
Interventions: intervention 1: Abraxane
Intervention descriptions: intervention 1: 220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.

Protocol documents: