Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006381
• Other study ID #: CDR0000068255
• Secondary ID: MSKCC-00078NCI-G
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2000
• Last updated: December 18, 2013
• Start date: June 2000
• Est. completion date: February 2004

Study information

• Verified date: December 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• trastuzumab

Drug:
• celecoxib

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,