Irinotecan and Cetuximab in Treating Patients With Metastatic Breast Cancer

December 9, 2016 updated by: Alliance for Clinical Trials in Oncology

Phase II Trial of Concurrent Irinotecan Plus Cetuximab in Patients With Advanced Breast Cancer With Prior Anthracycline and/or Taxane-Containing Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cetuximab + irinotecan

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.
Drug: irinotecan hydrochloride
Biological: cetuximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Confirmed tumor response (complete or partial)
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to disease progression
Time Frame: Up to 5 years
Up to 5 years
Survival time
Time Frame: Up to 5 years
Up to 5 years
Progression-free survival at 6 months
Time Frame: at 6 months
at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Timothy Hobday, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

January 10, 2006

First Submitted That Met QC Criteria

January 10, 2006

First Posted (Estimate)

January 11, 2006

Study Record Updates

Last Update Posted (Estimate)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 9, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCTG-N0436
  • NCI-2012-02679 (Registry Identifier: CTRP (Clinical Trials Reporting System))
  • CDR0000456255 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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