Phase II Study of Abraxane in CIMP-High Colorectal Adenocarcinomas and Small Bowel Adenocarcinomas
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 25 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma
Sample size of 15 patients with CIMP-high required to demonstrate a response rate of 20% using a binomial one-sample test with a two-sided alpha of 0.025 and power of 91%. For second disease group, 10 small intestinal adenocarcinomas patients enrolled to test if a null hypothesis of ≤1% response rate is different from an alternative hypothesis of a response rate of 20% using a binomial one-sample test with a two-sided alpha of 0.025 and power of 0.85. A Bonferroni's correction used to account for the multiple testing (overall alpha=0.05/2 tests). Pearson chi-square (or Fisher's exact test) or t-test (or Wilcoxon rank test) used to determine differences between responder and non-responders.
21 days
No
Michael Overman, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2012-0776
NCT01730586
November 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |