Clinical trial NCT00006381: Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Chau T. Dang, MD
role: STUDY_CHAIR
References: