Overview
Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer
Status:
Terminated
Terminated
Trial end date:
2010-01-01
2010-01-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. It is not yet known which regimen of celecoxib is more effective in treating breast cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of celecoxib in treating women who have metastatic or recurrent breast cancerPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Alliance for Clinical Trials in OncologyCollaborator:
National Cancer Institute (NCI)Treatments:
Celecoxib
Criteria
DISEASE CHARACTERISTICS:- Histologically confirmed invasive breast cancer
- Metastatic or recurrent disease documented by physical or radiographic
examination
- Isolated recurrence of breast cancer not considered eligible
- Bone disease alone allowed
- At least 4 prior courses (or 4 months) of chemotherapy resulting in stable disease,
partial response, or complete response
- Treated brain metastases allowed provided all of the following conditions are met:
- Palliation achieved without evidence of progression for at least 3 months after
completion of radiotherapy and/or surgical treatment
- At least 30 days since prior dexamethasone or other corticosteroids
- Documentation of another site of metastatic disease (in addition to brain
metastases)
- Measurable or evaluable disease
- Pleural or peritoneal effusion as only manifestation of disease allowed if palliated
by prior chemotherapy
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Not specified
Performance status
- CTC (ECOG) 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST or ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
- Albumin at least 3.0 g/dL
Renal
- Creatinine no greater than 1.5 times ULN
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other active malignancy within the past 2 years except nonmelanoma skin cancer
- No active peptic ulcer disease
- No known hypersensitivity to sulfonamides, aspirin, or other NSAIDs, including
celecoxib
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Concurrent trastuzumab (Herceptin) allowed if initiated at least 3 months prior to
study entry
Chemotherapy
- See Disease Characteristics
- At least 6 weeks since prior chemotherapy
- No more than 2 prior chemotherapy regimens for recurrent or metastatic disease
Endocrine therapy
- See Disease Characteristics
- Prior hormonal therapy for metastatic disease allowed
- No concurrent hormonal therapy except hormones for noncancer-related conditions (e.g.,
insulin for diabetes)
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- Prior radiotherapy to the breast and for metastatic disease allowed
- No concurrent palliative radiotherapy
Surgery
- See Disease Characteristics
Other
- Prior adjuvant therapy for metastatic disease allowed
- Concurrent bisphosphonates allowed
- Concurrent low-dose aspirin (no greater than 325 mg/day) is allowed
- No other concurrent therapy with celecoxib or other nonsteroidal anti-inflammatory
drugs (NSAIDs) (e.g., rofecoxib, aspirin, choline magnesium trisalicylate, ibuprofen,
naproxen, etodolac, oxaprozin, diflunisal, nabumetone, or tolmetin)
- No concurrent fluconazole