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Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design



- Compare the progression-free survival of women with metastatic or recurrent breast
cancer treated with 2 dose levels of celecoxib.


- Compare the side effects of the 2 dose levels of this drug in these patients.

- Compare the overall survival of patients treated with the 2 dose levels of this drug.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to disease status at study entry (complete response vs partial response vs stable)
and prior metastatic/recurrent chemotherapy regimens (1 vs 2). Patients are randomized to 1
of 2 treatment arms.

- Arm I: Patients receive oral high-dose celecoxib twice daily.

- Arm II: Patients receive oral low-dose celecoxib twice daily. In both arms, treatment
continues until first disease progression. At disease progression, treatment assignment
is unblinded and treatment may continue at the treating physician's discretion.
Patients initially randomized to the low-dose arm may either continue on that dosage or
crossover to the high-dose arm. Patients initially randomized to the high-dose arm may
continue on that dosage. Treatment after disease progression may continue for up to 12

Patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.

PROJECTED ACCRUAL: A total of 132 patients (88 in the high-dose arm and 44 in the low-dose
arm) will be accrued for this study within 22 months.

Inclusion Criteria


- Histologically confirmed invasive breast cancer

- Metastatic or recurrent disease documented by physical or radiographic

- 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

- Measurable or evaluable disease

- Pleural or peritoneal effusion as only manifestation of disease allowed if palliated
by prior chemotherapy

- Hormone receptor status:

- Not specified



- 18 and over


- Female

Menopausal status

- Not specified

Performance status

- CTC (ECOG) 0-2

Life expectancy

- Not specified


- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3


- 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


- Creatinine no greater than 1.5 times ULN


- 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


Biologic therapy

- Concurrent trastuzumab (Herceptin) allowed if initiated at least 3 months prior to
study entry


- 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)


- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- Prior radiotherapy to the breast and for metastatic disease allowed

- No concurrent palliative radiotherapy


- See Disease Characteristics


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

28 months

Safety Issue:


Principal Investigator

Charles L. Shapiro, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • Breast Neoplasms



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