Radiolabeled Monoclonal Antibody Therapy, Combination Chemotherapy, and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
| Status: | Archived |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2011 |
Phase I Trial of Radioimmunotherapy (Y-90 M5A) in Combination With FOLFIRI and Bevacizumab Chemotherapy for Metastatic Colorectal Carcinoma
RATIONALE: Radiolabeled monoclonal antibodies can find tumor cells and either kill them or
carry tumor-killing substances to them without harming normal cells. Giving radioactive
substances together with antibodies may be effective treatment for some advanced cancers.
Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, and leucovorin
calcium (FOLFIRI), work in different ways to stop the growth of tumor cells, either by
killing the cells or by stopping them from dividing. Monoclonal antibodies, such as
bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells
to grow and spread. Others find tumor cells and help kill them or carry tumor-killing
substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood
flow to the tumor. Giving radiolabeled monoclonal antibodies together with combination
chemotherapy and bevacizumab may be an effective treatment for colorectal cancer. PURPOSE:
This phase I trial is studying the side effects, best way to give, and best dose of yttrium
Y 90 DOTA anti-CEA (Carcinoembryonic antigen) monoclonal antibody M5A when given together
with combination chemotherapy and bevacizumab in treating patients with metastatic
colorectal cancer.
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of a combination of FOLFIRI
chemotherapy, and intravenous yttrium-90 (90Y) M5A anti-CEA antibody. SECONDARY
OBJECTIVES:I. To study the progression free survival and response rate of this combined
treatment in patients with stage IV colorectal cancer.II. To evaluate the biodistribution,
clearance and metabolism of 90Y and 111In (indium-111) M5A administered
intravenously.OUTLINE: This is a dose-escalation study of yttrium Y 90 DOTA anti-CEA
monoclonal antibody M5A. Patients receive irinotecan hydrochloride IV over 90 minutes,
leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and
bevacizumab IV over 30-90 minutes once every 2 weeks. Patients also receive yttrium Y 90
DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes once in weeks 3 and 9. Treatment
continues in the absence of disease progression or unacceptable toxicity.
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