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Sponsored by: |
Ludwig Institute for Cancer Research |
Information provided by: | Ludwig Institute for Cancer Research |
ClinicalTrials.gov Identifier: | NCT00199797 |
Although treatment for metastatic colo-rectal 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 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 application of the huA33 antibody may delay the growth of tumor cells producing the respective antigen. Oxaliplatin and 5-FU are cytotoxic agents which are considered as standard treatment in metastatic colorectal cancer. Leucovorin is a vitamin which enhances the effect of 5FU. Eligible patients with advanced colorectal cancer will receive huA33, 10 mg/m2 by intravenous (IV) infusion weekly for twelve weeks. On Study Day 15 (week 3), 5-FU, leucovorin (folinic acid), 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 antibody (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 + 5FU + leucovorin + oxaliplatin. The secondary objective is to measure the immunogenicity of huA33 when given in combination with 5FU plus leucovorin with oxaliplatin and to document tumor responses.
Condition | Intervention | Phase |
Colorectal Cancer |
Drug: huA33 antibody plus chemotherapy |
Phase I |
MedlinePlus related topics: | Cancer Colorectal Cancer |
Drug Information available for: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Oxaliplatin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Trial of huA33 Plus 5-Fluorouracil (5FU), Leucovorin and Oxaliplatin in Patients With Metastatic Colorectal Cancer |
Enrollment: | 20 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
huA33 will be administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2. Every second week, Oxaliplatin, 5-FU and Leucovorin are administered additionally. Oxaliplatin and Leucovorin will be given as an infusion over 2 hours. Afterwards patients will receive an bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.
The doses of Oxaliplatin will be 85mg/m2, Leucovorin 200mg/m2, 400mg/m2 of 5-FU as an bolus infusion and 600mg/m2 as an continuous infusion. A complete treatment cycle consists of 12 weekly treatment days.
Purpose of the Research Study:
huA33 is an antibody that reacts with the A33 antigen which is produced by colorectal cancers. Prior studies have shown that application of the huA33 antibody may delay the growth of tumor cells producing the respective antigen.
Oxaliplatin and 5-FU are cytotoxic agents which are considered as standard treatment in metastatic colorectal cancer. Leucovorin is a vitamin which enhances the effect of 5FU.
The primary purpose of this study is to determine whether the combination huA33 plus Oxaliplatin, 5-FU and Leucovorin is safe and what side effects occur.
Description of Research Procedures:
The first step is to determine whether or not patients are eligible for participation in the study. Apart from general blood tests and x-ray studies needed, this involves testing with regard to some special requirements:
After eligibility is established, huA33 will be administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2. Every second week, Oxaliplatin, 5-FU and Leucovorin are administered additionally. Oxaliplatin and Leucovorin will be given as an infusion over 2 hours. Afterwards patients will receive an bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.
The doses of Oxaliplatin will be 85mg/m2, Leucovorin 200mg/m2, 400mg/m2 of 5-FU as an bolus infusion and 600mg/m2 as an continuous infusion. A complete treatment cycle consists of 12 weekly treatment days.
Patients will have an interview with their doctor and a physical examination before the first day of treatment and before each therapy. Standard blood tests as well as special blood tests to measure a possible reaction of the immune system to the huA33 antibody will be done weekly before the treatment is started. The amount of blood to be drawn will be 20-30 ml during one cycle of the study.
X-rays and/or CT scans to measure the extend of the disease will be done at the start and on week 12, which is considered to be the first day of the next cycle. Patients may continue with this treatment until there is no evidence of tumor progression.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be eligible for enrollment if they fulfill all of the following criteria:
Within the 2 weeks prior to the first dose of huA33, the following vital laboratory parameters:
Lab Parameter Range
Exclusion Criteria:
Patients will be excluded from the study for any of the following reasons:
Germany | |||||
Krankenhaus Nordwest | |||||
Frankfurt, Germany, 60488 | |||||
Switzerland | |||||
UniversitaetsSpital Zuerich | |||||
Zurich, Switzerland, CH-8091 |
Ludwig Institute for Cancer Research |
Principal Investigator: | Christoph Renner, MD | Universitätsspital Zürich, Switzerland |
Principal Investigator: | Alexander Knuth, MD | Universitätsspital Zürich, Switzerland |
Principal Investigator: | Elke Jäger, MD | Krankenhaus Nordwest, Germany |
Responsible Party: | Ludwig Institute for Cancer Research ( Ralph Venhaus, MD Head of Clinical and Regulatory Affairs ) |
Study ID Numbers: | LUD2003-005 |
First Received: | September 12, 2005 |
Last Updated: | January 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00199797 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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