Monoclonal Antibody Therapy in Treating Patients With Advanced 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. Identifier: NCT00006046
Recruitment Status : Completed
First Posted : May 21, 2003
Last Update Posted : February 9, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

July 5, 2000
May 21, 2003
February 9, 2009
January 2000
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Complete list of historical versions of study NCT00006046 on Archive Site
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Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
Phase I Study of Humanized 3S193 (Anti-Lewis-Y) Antibody in Patients With Advanced Colorectal Carcinoma

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer.


  • Determine the toxicity, maximum tolerated dose, and pharmacokinetics of monoclonal antibody Hu3S193 in patients with advanced colorectal carcinoma.
  • Determine the immune response in these patients treated with this regimen.

OUTLINE: This is a dose escalation study.

Patients receive monoclonal antibody Hu3S193 (MAB Hu3S193) IV over 30 minutes to 4 hours weekly for 8 weeks followed by 2 weeks of rest. Patients with stable or responding disease at week 10 receive maintenance MAB Hu3S193 weekly. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of MAB Hu3S193 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicities.

PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study.

Phase 1
Primary Purpose: Treatment
Colorectal Cancer
Biological: monoclonal antibody Hu3S193
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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  • Histologically proven stage IV colorectal carcinoma

    • Failed or refused conventional chemotherapy
  • Lewis Y antigen present on more than 50% of tumor cells
  • Measurable or evaluable disease
  • No CNS tumor involvement



  • 18 and over

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • At least 6 weeks


  • Granulocyte count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin no greater than 1.0 mg/dL
  • Prothrombin time less than 1.3 times control


  • Creatinine no greater than 1.4 mg/dL


  • No New York Heart Association class III or IV heart disease


  • No serious infection requiring antibiotics or other serious illness
  • Not pregnant or nursing
  • No history of bleeding gastric ulcers or pancreatitis
  • No diabetes mellitus requiring insulin
  • Human antimouse antibody (HAMA) negative


Biologic therapy:

  • No prior mouse monoclonal antibody or antibody fragments
  • At least 4 weeks since other prior immunotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • No concurrent steroids or other antiinflammatory agents


  • At least 4 weeks since prior radiotherapy


  • Not specified
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Sydney Welt, MD Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP