Working… Menu

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: NCT00027729
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 5, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

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/II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer that has not responded to irinotecan.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: etaracizumab Phase 1 Phase 2

Detailed Description:


  • Determine the recommended phase II dose of monoclonal antibody anti-anb3 integrin in patients with irinotecan-refractory advanced colorectal cancer.
  • Determine the safety and tolerance of this drug in these patients.
  • Determine any antitumor activity of this drug in these patients.
  • Determine the objective response rate, response duration, and time to progression in patients treated with this drug.
  • Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive monoclonal antibody anti-anb3 integrin IV over 30 minutes once weekly on weeks 1-52 in the absence of disease progression or unacceptable toxicity. Patients with responding disease may continue therapy.

Cohort of 4-6 patients receive escalating doses of monoclonal antibody anti-anb3 integrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose in the phase II portion of the study.

Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 4-24 patients will be accrued for phase I of this study and a total of 40 patients will be accrued for phase II of this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I/II Study of MEDI-522, A Humanized Monoclonal Antibody Directed Against the Human Alpha V Beta 3 Integrin, in Patients With Irinotecan-Refractory Advanced Colorectal Cancer
Study Start Date : June 2001
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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


  • Histologically confirmed advanced colorectal cancer
  • Disease progression while receiving an irinotecan-containing regimen for metastatic colorectal cancer OR
  • Disease recurrence within 6 months after completing an irinotecan-containing regimen in the adjuvant setting
  • At least 1 measurable lesion (for phase II only)

    • At least 20 mm by x-ray, CT scan, MRI, or photograph
    • Recurrent disease after surgery or radiotherapy is considered measurable if it has been at least 4 weeks since treatment and measurable disease is outside the port of prior radiotherapy or there is evidence of disease progression within the port of prior radiotherapy
    • The following are not considered measurable:

      • Pleural effusion
      • Ascites
      • Osteoblastic lesion or evidence of disease on bone scan alone
      • Progressive irradiated lesions alone
      • Bone marrow involvement
      • Brain metastases
      • Malignant hepatomegaly by physical exam alone
      • Chemical markers (e.g., carcinoembryonic antigen)
  • No known brain metastases or primary brain tumors
  • No symptomatic pleural effusion or ascites requiring paracentesis
  • No clinical evidence of bowel obstruction



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 10.0 g/dL


  • Bilirubin no greater than 2.0 mg/dL
  • AST/ALT no greater than 5 times upper limit of normal (ULN)
  • PT/PTT less than ULN OR
  • INR less than 1.12
  • No hepatitis virus infection


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 50 mL/min


  • No prior myocardial infarction
  • No angina
  • No uncontrolled hypertension (systolic blood pressure greater than 150 mm Hg)
  • No prior cerebrovascular accident or transient ischemic attack


  • No respiratory insufficiency requiring oxygen treatment
  • No lymphangitic involvement of lungs


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 30 days before, during, and for 30 days after study
  • Thyroxine and thyroid-stimulating hormone normal
  • No hematemesis, melena, hematochezia, or gross hematuria
  • No prior significant adverse reaction to a humanized monoclonal antibody
  • No known HIV infection
  • No active infection requiring systemic anti-infective therapy
  • No other medical or psychological condition or behavior, including substance dependence or abuse, that would preclude study
  • No other malignancy within the past 5 years except basal cell skin cancer or completely excised carcinoma in situ of the cervix


Biologic therapy:

  • Prior immunotherapy with approved agents allowed
  • No prior monoclonal antibody anti-anb3 integrin or its precursor (MEDI-523)
  • No other concurrent immunotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • No concurrent palliative chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy


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


  • See Disease Characteristics
  • At least 4 weeks since prior surgery and surgical wounds must have healed


  • Recovered from all prior therapy
  • At least 4 weeks since prior investigational agents

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 identifier (NCT number): NCT00027729

Layout table for location information
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Leonard B. Saltz, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00027729    
Other Study ID Numbers: 01-078
CDR0000069061 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent colon cancer
recurrent rectal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases