A Phase II Trial of Radioimmunotherapy (Y-90 M5A) Following Hepatic Resection and FOLFIRI or FOLFOX Chemotherapy [+/-BEVACIZUMAB], or Xelox for Metastatic Colorectal Carcinoma to the Liver
PRIMARY OBJECTIVES:
I. To determine the progression free survival in colorectal cancer patients after hepatic
resection of liver metastases and FOLFOX or leucovorin calcium, fluorouracil, and irinotecan
hydrochloride (FOLFIRI) chemotherapy [+/- Bevacizumab], or capecitabine and oxaliplatin
(XELOX),followed by intravenous (IV) yttrium-90 (90Y) M5A anti-CEA antibody.
SECONDARY OBJECTIVES:
I. To study the feasibility and toxicities of such adjuvant therapy following resection
and/or ablation of liver metastases and FOLFOX chemotherapy.
II. To evaluate the biodistribution, clearance and metabolism of 90Y and 111In (indium-111)
M5A administered IV.
OUTLINE:
FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin
calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV
over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease
progression or unacceptable toxicity.
RADIOIMMUNOTHERAPY (RIT): Within 4-12 weeks after completion of post-hepatic resection
therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV
over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease
progression or unacceptable toxicity.
NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy
comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours,
fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes.
Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up at 3 and 6 months.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
Estimated using the product-limit method of Kaplan-Meier, and 95% confidence limits calculated for these estimates.
1 year after completion of study treatment
No
Jeffrey Wong
Principal Investigator
City of Hope Medical Center
United States: Food and Drug Administration
09053
NCT01320683
March 2011
Name | Location |
---|---|
City of Hope Medical Center | Duarte, California 91010 |