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Monoclonal Antibody Plus Chemotherapy in Treating Patients With Advanced Colorectal Cancer That Overexpresses HER2

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: February 7, 2013
Last verified: June 2007
Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab and chemotherapy with irinotecan in treating patients who have stage IV colorectal cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

Condition Intervention Phase
Colorectal Cancer
Biological: trastuzumab
Drug: irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II and Pharmacokinetic Study of CPT-11 and Trastuzumab (RhuMab HER2, Herceptin) in Advanced Colo-Rectal Cancer With p185 HER 2 Overexpression

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Enrollment: 32
Study Start Date: September 1999
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive a loading dose of trastuzumab IV over 90 minutes on week 1, and over 30-90 minutes weekly thereafter. Patients receive irinotecan IV over 90 minutes following trastuzumab weekly for 4 weeks. Courses are repeated every 6 weeks in the absence of disease progression or unacceptable toxicity.
Biological: trastuzumab Drug: irinotecan hydrochloride

Detailed Description:


I. Determine the objective response rate of irinotecan and trastuzumab in patients with stage IV colorectal cancer and p185 HER2 overexpression.

II. Evaluate the safety and toxic effects of this treatment regimen in these patients.

III. Determine the overall survival and time to progression in these patients in response to this treatment regimen.

IV. Determine the pharmacokinetics of trastuzumab in combination with irinotecan and antibodies to trastuzumab in these patients.

V. Determine the expression of HER2/neu in these patients.

OUTLINE: This is a multicenter study.

Patients receive a loading dose of trastuzumab IV over 90 minutes on week 1, and over 30-90 minutes weekly thereafter. Patients receive irinotecan IV over 90 minutes following trastuzumab weekly for 4 weeks. Courses are repeated every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed stage IV colorectal cancer with p185 HER2 overexpression
  • Bidimensionally measurable disease Indicator lesion must be outside of irradiated field No symptomatic CNS brain metastases


  • Performance status: ECOG 0-2
  • Absolute granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 3.0 times ULN
  • Creatinine no greater than 2.0 mg/dL
  • LVEF at least 45% by MUGA or ECHO
  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • No unstable angina
  • No clinically significant pericardial effusion or arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study
  • No other prior malignancy within the past 5 years, except:

    • Curatively treated basal or squamous cell skin cancer
    • Curatively treated carcinoma in situ of the cervix
    • No active serious infection or serious underlying medical condition that would prevent compliance
    • No dementia or significantly altered mental status


  • Concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa allowed
  • No prior trastuzumab
  • No more than 1 prior chemotherapy regimen for advanced disease (if progressed during or within 6 months of adjuvant therapy considered to have had 1 regimen for advanced disease)
  • No prior irinotecan
  • Concurrent contraception, estrogen replacement therapy, or megestrol acetate for anorexia allowed
  • Greater than 3 weeks since prior radiotherapy and recovered
  • Greater than 3 weeks since major surgery (except simple biopsy or venous access placement) and recovered
  • At least 3 weeks since prior investigational nonneoplastic drugs
  Contacts and Locations
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Please refer to this study by its identifier: NCT00003995

United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Ramesh K. Ramanathan, MD University of Pittsburgh
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00003995     History of Changes
Other Study ID Numbers: NCI-2012-02307
CDR0000067205 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: November 1, 1999
Last Updated: February 7, 2013

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant 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
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017