Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer

December 18, 2013 updated by: Memorial Sloan Kettering Cancer Center

Phase II Study of Celecoxib in HER-2/Neu Overexpressing Metastatic Breast Cancer Patients Who Have Failed Recombinant Humanized Anti-p 185HER Monoclonal Antibody Trastuzumab (HERCEPTIN)

RATIONALE: Celecoxib may be effective in preventing the further development of cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining trastuzumab with celecoxib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and trastuzumab in treating women who have metastatic breast cancer that has not responded to previous trastuzumab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the efficacy of celecoxib and trastuzumab (Herceptin) in women with HER2/neu-overexpressing metastatic breast cancer that is refractory to prior trastuzumab.
  • Determine the safety of celecoxib in these patients.

OUTLINE: At least 3 weeks after the last dose of prior chemotherapy, patients receive oral celecoxib twice daily. Patients continue or restart trastuzumab (Herceptin) IV over 30-90 minutes weekly or every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within approximately 9 months.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

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

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically proven metastatic breast cancer

    • HER2/neu-positive (overexpressing) tumor tissue
  • Failed prior trastuzumab (Herceptin) therapy with or without chemotherapy
  • Resected stage IV disease allowed if evidence of disease

  • Bidimensionally measurable or evaluable disease

    • No lesions in previously irradiated field except nonbone lesions progressive after radiotherapy
    • No pleural effusions
    • No blastic or mixed bony metastases
    • No palpable abdominal masses
  • No leptomeningeal disease

  • Brain metastases allowed if:

    • No concurrent use of steroids
    • At least 3 months since prior brain irradiation
    • No evidence of progression of metastases

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Hemoglobin at least 8.0 g/dL
  • Platelet count at least 100,000/mm^3

Hepatic:

  • AST/ALT no greater than 2 times upper limit of normal (ULN)
  • Bilirubin no greater than 1.5 times ULN

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • LVEF at least 50%

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No other serious medical illness
  • No severe infection
  • No severe malnutrition
  • No prior allergic reactions to sulfonamides or celecoxib

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • Prior trastuzumab (Herceptin) for breast cancer allowed, either as adjuvant/neoadjuvant or for metastatic disease

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Prior cytotoxic therapy for breast cancer allowed, either as adjuvant/neoadjuvant or for metastatic disease

Endocrine therapy:

  • See Disease Characteristics
  • At least 3 weeks since prior hormonal therapy
  • Prior exogenous hormonal therapy for stage IV disease and/or as adjuvant therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • Prior localized radiotherapy allowed if no influence on the signal measurable lesion
  • Concurrent localized radiotherapy allowed if no influence on the signal measurable lesion

Surgery:

  • See Disease Characteristics
  • At least 3 weeks since prior major surgery and recovered
  • At least 2 weeks since prior minor surgery and recovered

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

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Chau T. Dang, MD, Memorial Sloan Kettering Cancer Center

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

June 1, 2000

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

October 4, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068255
  • MSKCC-00078
  • NCI-G00-1869

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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