Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer

This study has been terminated.
(Poor accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00045591
First received: September 6, 2002
Last updated: September 26, 2013
Last verified: September 2013
  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 2

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:


Further study details as provided by Alliance for Clinical Trials in Oncology:

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
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Charles L. Shapiro, MD Ohio State University Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00045591     History of Changes
Other Study ID Numbers: CDR0000256905, U10CA031946, CALGB-40105
Study First Received: September 6, 2002
Last Updated: September 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
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 April 16, 2014