Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00045591

Purpose

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 cancer

Condition	Intervention	Phase
Breast Cancer	Drug: celecoxib Drug: Celecoxib	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:

Progression free survival [ Time Frame: 28 months ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	February 2003
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Celecoxib 100 mg	Drug: celecoxib 100 mg PO bid
Experimental: Celecoxib 400 mg	Drug: Celecoxib 400 mg PO bid

Detailed Description:

OBJECTIVES:

Primary

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

Secondary

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 months.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045591

Show 74 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles L. Shapiro, MD

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information

No publications provided

Responsible Party:	Monica M Bertagnolli, MD, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00045591 History of Changes
Other Study ID Numbers:	CDR0000256905, U10CA031946, CALGB-40105
Study First Received:	September 6, 2002
Last Updated:	June 21, 2011
Health Authority:	United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:

recurrent breast cancer
stage IV breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012