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Trial record 10 of 722 for:    colon cancer AND 5-FU

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00199797
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 3, 2009
Sponsor:
Information provided by:
Ludwig Institute for Cancer Research

Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cancer Drug: huA33 antibody plus chemotherapy Phase 1

Detailed Description:

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:

  • Three tests of stool to determine if it is positive for blood.
  • Women of childbearing age must have a negative pregnancy test.
  • If patients ever had a treatment with similar substances like huA33 before, a blood sample needs to be tested for antibodies that may have developed against huA33.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of huA33 Plus 5-Fluorouracil (5FU), Leucovorin and Oxaliplatin in Patients With Metastatic Colorectal Cancer
Study Start Date : October 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: huA33 antibody plus chemotherapy

    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.



Primary Outcome Measures :
  1. To determine the safety of the combination of huA33 and 5FU plus leucovorin and oxaliplatin in patients with metastatic colorectal cancer [ Time Frame: Duration of study ]

Secondary Outcome Measures :
  1. To measure the immunogenicity of huA33 when given in combination with 5FU plus leucovorin with oxaliplatin [ Time Frame: Duration of study ]
  2. To document tumor responses in patients receiving huA33 and 5FU plus leucovorin and oxaliplatin. [ Time Frame: Duration of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will be eligible for enrollment if they fulfill all of the following criteria:

  1. Metastatic colorectal cancer
  2. Histologically or cytologically proven colorectal cancer
  3. Expected survival of at least 4 months.
  4. Not more than 2 different pretreatment regimens
  5. ECOG performance status 0-2.
  6. Within the 2 weeks prior to the first dose of huA33, the following vital laboratory parameters:

    Lab Parameter Range

    • Neutrophil count > 1.5 x 109/L
    • Platelet count > 150 x 109/L
    • Serum bilirubin < 2 mg/dL
    • Creatinine clearance >50 ml/ min
  7. Age ≥ 18 years
  8. Able and willing to give valid written informed consent

Exclusion Criteria:

Patients will be excluded from the study for any of the following reasons:

  1. Untreated active metastatic disease to the central nervous system defined as new or enlarging lesions on CT or MRI.
  2. Surgery or radiotherapy of brain metastases within 3 months prior to the first dose of huA33.
  3. Metastatic disease involving > 50% of liver volume.
  4. Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
  5. Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing (6 weeks for nitrosoureas).
  6. Previous treatment with Oxaliplatin.
  7. Previous treatment with huA33 monoclonal antibody or antibody fragment.
  8. Concomitant treatment with systemic corticosteroids. Topical or inhalational corticosteroids are permitted.
  9. Known HIV, Hepatitis B or C positivity.
  10. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  11. Lack of availability of the patient for clinical and laboratory follow-up assessment.
  12. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
  13. Pregnancy or breastfeeding.
  14. Women of childbearing potential: Refusal or inability to use effective means of contraception.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199797


Locations
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Germany
Krankenhaus Nordwest
Frankfurt, Germany, 60488
Switzerland
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Investigators
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Principal Investigator: Christoph Renner, MD Universitätsspital Zürich, Switzerland
Principal Investigator: Alexander Knuth, MD Universitätsspital Zürich, Switzerland
Principal Investigator: Elke Jäger, MD Krankenhaus Nordwest, Germany

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Responsible Party: Ralph Venhaus, MD Head of Clinical and Regulatory Affairs, Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00199797     History of Changes
Other Study ID Numbers: LUD2003-005
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 3, 2009
Last Verified: March 2009
Keywords provided by Ludwig Institute for Cancer Research:
Colorectal Cancer
huA33
antibody
chemotherapy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents