At a glance
ClinicalIndex Comparison Record- ✓Metastatic colorectal cancer with histologic or cytologic confirmation
- ✓Expected survival of at least 4 months
- ✓No more than 2 prior chemotherapy regimens
- ✓Age ≥18 years
- ✕Untreated active brain metastases (new or enlarging lesions on imaging)
- ✕Prior brain surgery or radiotherapy within 3 months
- ✕Metastatic disease involving >50% of liver volume
- ✕Prior treatment with oxaliplatin
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Trial of huA33 Plus 5-fluorouracil (5-FU), Leucovorin and Oxaliplatin in Patients With Metastatic Colorectal Cancer
In Brief
A Phase 1 clinical trial evaluating Oxaliplatin, 5-Fluorouracil, and 2 other interventions for Colorectal Cancer. Completed, enrolled 20 participants across 2 sites in 2 countries.
Detailed Summary
Although treatment for metastatic colorectal cancer has improved significantly over the recent years, it still remains a significant health problem representing the leading cancer by incidence in the United States of America. In the search for new therapies, monoclonal antibodies have been developed to specifically target human colon cancer cells. huA33 is an antibody that reacts with the A33 antigen which is produced by colorectal cancers. Prior studies have shown that administration of the huA33 antibody may delay the growth of tumor cells producing the specific antigen. Oxaliplatin and 5-fluorouracil (5-FU) are cytotoxic agents which are considered as standard treatment in metastatic colorectal cancer. Leucovorin (folinic acid) is a vitamin which enhances the effect of 5-FU. Eligible patients with advanced colorectal cancer will receive huA33 10 mg/m2 by intravenous (IV) infusion weekly for twelve weeks. Starting on Study Day 15 (week 3), 5-FU, leucovorin, and oxaliplatin will be administered every 2 weeks for 10 weeks. Patients will be evaluated weekly for toxicity. Blood samples will be obtained every week for hematology and serum biochemistry analysis and for determination of human anti-human antibodies (HAHA). In patients with measurable disease, tumors will be assessed by the appropriate scan at baseline and at the end of the thirteen week cycle. The primary objective of this study is to assess the safety of huA33 + 5-FU + leucovorin + oxaliplatin. The secondary objective is to measure the immunogenicity of huA33 when given in combination with 5-FU plus leucovorin and oxaliplatin and to document tumor responses.
Study Details
Timeline
Interventions
Oxaliplatin was administered at 85 mg/m2 on day 2 of every 2 week regimen.
The dose of 5-FU was 400 mg/m2 IV bolus followed by continuous IV infusion at 600 mg/m2 over 22 hours on day 2 and day 3 of every 2 week regimen.
Leucovorin was administered at a dose of 200mg/m2 on day 2 and day 3 of every 2 week regimen.
huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2.