Colorectal Cancer Clinical Trial
Official title:
Phase II Study of Abraxane in CIMP-High Colorectal Adenocarcinomas and Small Bowel Adenocarcinomas
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |