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Phase I Trial of huA33 Plus Chemotherapy in Patients With Metastatic Colorectal Cancer

NCT00199797 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-10-10

Study results available
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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.

Conditions

Interventions

DRUG

Oxaliplatin

Oxaliplatin was administered at 85 mg/m2 on day 2 of every 2 week regimen.

DRUG

5-Fluorouracil

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.

DRUG

Leucovorin

Leucovorin was administered at a dose of 200mg/m2 on day 2 and day 3 of every 2 week regimen.

DRUG

huA33

huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2.

Sponsors & Collaborators

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • Christoph Renner, MD · Universitätsspital Zürich, Switzerland

  • Alexander Knuth, MD · Universitätsspital Zürich, Switzerland

  • Elke Jäger, MD · Krankenhaus Nordwest, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-18
Primary Completion
2006-11-08
Completion
2016-04-01

Countries

  • Germany
  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00199797 on ClinicalTrials.gov