Irinotecan and Cetuximab in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: January 10, 2006
Last updated: November 5, 2011
Last verified: February 2009

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving irinotecan together with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with cetuximab works in treating patients with metastatic breast cancer.

Condition Intervention Phase
Breast Cancer
Biological: cetuximab
Drug: irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Concurrent Irinotecan Plus Cetuximab in Patients With Advanced Breast Cancer With Prior Anthracycline and/or Taxane-Containing Therapy

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Confirmed tumor response (complete or partial) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression [ Designated as safety issue: No ]
  • Survival time [ Designated as safety issue: No ]
  • Progression-free survival at 6 months [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: February 2006
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Detailed Description:



  • Determine the antitumor activity, by confirmed response rate, of concurrent irinotecan hydrochloride and cetuximab in patients with metastatic breast cancer with prior anthracycline and/or taxane-containing therapy.


  • Estimate 6-month, progression-free survival of patients.
  • Evaluate the adverse event profile of irinotecan hydrochloride in combination with cetuximab in patients with metastatic breast cancer.
  • Estimate progression-free survival of patients.
  • Estimate overall survival.

OUTLINE: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and irinotecan hydrochloride IV over 1½ hours on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the breast

    • Clinical manifestations of metastatic disease
  • If patient's tumor is HER2 positive (3+ by immunohistochemistry [IHC] or amplified by fluorescent in situ hybridization [FISH]), must have received at least one prior trastuzumab (Herceptin)-containing regimen unless there is a contraindication
  • Measurable disease defined as at least one lesion whose longest diameter can be accurately measured

    • The only evidence of metastasis must not be bone metastases or other non-measurable disease
    • Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter < 2 cm) and truly nonmeasurable lesions which include any of the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Cystic lesions
      • Abdominal masses that are not confirmed and followed by imaging techniques
  • No known CNS metastasis unless controlled by prior surgery and/or radiotherapy

    • To be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry
  • Hormone receptor status

    • Not specified


  • Men or women
  • Menopausal status not specified
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • Hemoglobin > 8.0 g/dL
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • AST and ALT ≤ 5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must employ adequate contraception (as determined by the treating physician) during treatment and for 30 days after treatment ends
  • Disease-free for ≥ 3 years of other invasive non-breast malignancies (exception: curatively treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix)
  • No history of allergy or hypersensitivity to drug product excipients, murine antibodies, or agents chemically similar to irinotecan and/or cetuximab
  • No history or evidence of Gilbert's syndrome
  • No active, unresolved infection
  • No New York Heart Association class III or IV cardiovascular disease
  • No serious concomitant medical condition that would make it undesirable for patient to participate in the trial or would jeopardize compliance with protocol treatment


  • See Disease Characteristics
  • No more than 2 prior chemotherapy regimens in the metastatic setting (irrespective of hormonal therapy or prior trastuzumab therapy)

    • Prior treatment in the metastatic or adjuvant setting must have included an anthracycline or a taxane
  • No major surgery ≤ 3 weeks prior to registration
  • No chemotherapy ≤ 2 weeks prior to registration
  • No radiotherapy ≤ 4 weeks prior to registration
  • No prior irinotecan hydrochloride
  • No prior therapy with an epidermal growth factor receptor (EGFR) antagonist (either monoclonal antibody or tyrosine kinase inhibitor), such as gefitinib or erlotinib
  • No prior therapy with a dual EGFR/HER2 inhibitor (e.g., lapatinib)
  • No concurrent interleukin-11(oprelvekin)
  • Routine use of granulocyte colony stimulating factors (CSFs) is not permitted during course 1 of this study

    • Subsequent use of CSFs is permitted at the discretion of the treating investigator
  • No other concurrent antitumor therapy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00275041

Sponsors and Collaborators
North Central Cancer Treatment Group
Study Chair: Timothy Hobday, MD Mayo Clinic
Investigator: Edith A. Perez, MD Mayo Clinic
Investigator: Matthew P. Goetz, MD Mayo Clinic
  More Information

Additional Information:
Publications: Identifier: NCT00275041     History of Changes
Other Study ID Numbers: CDR0000456255, NCCTG-N0436
Study First Received: January 10, 2006
Last Updated: November 5, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage IV breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on July 01, 2015