Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer

NCT ID: NCT00006381

Last Updated: 2013-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2004-02-29

Brief 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.

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

trastuzumab

Intervention Type: BIOLOGICAL

celecoxib

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Chau T. Dang, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

MSKCC-00078

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1869

Identifier Type: -

Identifier Source: secondary_id

CDR0000068255

Identifier Type: -

Identifier Source: org_study_id