drugset / Trial / NCT00291486
Capecitabine and 131I-huA33 in Patients With Metastatic Colorectal Cancer
Phase 1
Completed
19 enrolled
Ludwig Institute for Cancer Research
National Cancer Institute (NCI) · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this clinical trial is to determine whether it is safe to treat patients with advanced colorectal cancer, with humanised A33 antibody tagged with radioactive iodine (131I-huA33) in combination with chemotherapy (capecitabine).
Timeline
- Start
- 2003-10
- Primary completion
- 2008-01-03
- Completion
- 2012-08-29
Publications
- Background Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.
- Results Herbertson RA, Tebbutt NC, Lee FT, Gill S, Chappell B, Cavicchiolo T, Saunder T, O'Keefe GJ, Poon A, Lee ST, Murphy R, Hopkins W, Scott FE, Scott AM. Targeted chemoradiation in metastatic colorectal cancer: a phase I trial of 131I-huA33 with concurrent capecitabine. J Nucl Med. 2014 Apr;55(4):534-9. doi: 10.2967/jnumed.113.132761. Epub 2014 Feb 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 131I-huA33 | Monoclonal antibody | 20 unknown | Intravenous |
| Subject | 131I-huA33 | Monoclonal antibody | 30 unknown | Intravenous |
| Subject | 131I-huA33 | Monoclonal antibody | 40 unknown | Intravenous |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 1500 mg/m2 | Oral |