 |
 |
Clinical Trial Name - Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer
| Original Study ID : CDR0000256905 |
| Secondary ID : CALGB-40105 |
| NCT ID : NCT00045591 |
| Brief Title : Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer |
| Official Title : Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design |
| Brief 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 cancer |
| Source : National Cancer Institute (NCI) |
| 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. |
| Overall Status : Active, not recruiting |
| Start Date : February 2003 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double-Blind, Active Control |
| Verification Date : July 2004 |
| First Received Date : September 6, 2002 |
| Trial Eligibility |
| 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 |
| Gender : Female |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Northeast Alabama Regional Medical Center |
| City : Anniston |
| State : Alabama |
| Zip Code : 36207 |
| Country : United States |
| Facility Name : Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center |
| City : Los Angeles |
| State : California |
| Zip Code : 90048 |
| Country : United States |
| Facility Name : Naval Medical Center - San Diego |
| City : San Diego |
| State : California |
| Zip Code : 92134-3202 |
| Country : United States |
| Facility Name : Rebecca and John Moores UCSD Cancer Center |
| City : La Jolla |
| State : California |
| Zip Code : 92093-0658 |
| Country : United States |
| Facility Name : UCSF Comprehensive Cancer Center |
| City : San Francisco |
| State : California |
| Zip Code : 94115 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - San Diego |
| City : San Diego |
| State : California |
| Zip Code : 92161 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - San Francisco |
| City : San Francisco |
| State : California |
| Zip Code : 94121 |
| Country : United States |
| Facility Name : CCOP - Christiana Care Health Services |
| City : Newark |
| State : Delaware |
| Zip Code : 19713 |
| Country : United States |
| Facility Name : Lombardi Cancer Center at Georgetown University Medical Center |
| City : Washington |
| State : District of Columbia |
| Zip Code : 20007 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Washington, DC |
| City : Washington |
| State : District of Columbia |
| Zip Code : 20422 |
| Country : United States |
| Facility Name : Walter Reed Army Medical Center |
| City : Washington |
| State : District of Columbia |
| Zip Code : 20307-5001 |
| Country : United States |
| Facility Name : Broward General Medical Center |
| City : Fort Lauderdale |
| State : Florida |
| Zip Code : 33316 |
| Country : United States |
| Facility Name : CCOP - Mount Sinai Medical Center |
| City : Miami Beach |
| State : Florida |
| Zip Code : 33140 |
| Country : United States |
| Facility Name : Memorial Regional Cancer Center at Memorial Regional Hospital |
| City : Hollywood |
| State : Florida |
| Zip Code : 33021 |
| Country : United States |
| Facility Name : CCOP - Illinois Oncology Research Association |
| City : Peoria |
| State : Illinois |
| Zip Code : 61615-7828 |
| Country : United States |
| Facility Name : Lagrange Oncology Associates |
| City : La Grange |
| State : Illinois |
| Zip Code : 60525 |
| Country : United States |
| Facility Name : MBCCOP - University of Illinois at Chicago |
| City : Chicago |
| State : Illinois |
| Zip Code : 60612 |
| Country : United States |
| Facility Name : University of Chicago Cancer Research Center |
| City : Chicago |
| State : Illinois |
| Zip Code : 60637-1470 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Chicago (Westside Hospital) |
| City : Chicago |
| State : Illinois |
| Zip Code : 60612 |
| Country : United States |
| Facility Name : West Suburban Center for Cancer Care |
| City : River Forest |
| State : Illinois |
| Zip Code : 60305 |
| Country : United States |
| Facility Name : CCOP - Northern Indiana CR Consortium |
| City : South Bend |
| State : Indiana |
| Zip Code : 46601 |
| Country : United States |
| Facility Name : Fort Wayne Medical Oncology and Hematology, Incorporated |
| City : Fort Wayne |
| State : Indiana |
| Zip Code : 46885-5099 |
| Country : United States |
| Facility Name : Holden Comprehensive Cancer Center at University of Iowa |
| City : Iowa City |
| State : Iowa |
| Zip Code : 52242-1009 |
| Country : United States |
| Facility Name : Baptist Hospital East - Louisville |
| City : Louisville |
| State : Kentucky |
| Zip Code : 40207 |
| Country : United States |
| Facility Name : Greenebaum Cancer Center at University of Maryland Medical Center |
| City : Baltimore |
| State : Maryland |
| Zip Code : 21201 |
| Country : United States |
| Facility Name : Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute |
| City : Boston |
| State : Massachusetts |
| Zip Code : 02115 |
| Country : United States |
| Facility Name : UMASS Memorial Cancer Center - University Campus |
| City : Worcester |
| State : Massachusetts |
| Zip Code : 01655 |
| Country : United States |
| Facility Name : Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph |
| City : Saint Joseph |
| State : Michigan |
| Zip Code : 49085 |
| Country : United States |
| Facility Name : University of Minnesota Cancer Center |
| City : Minneapolis |
| State : Minnesota |
| Zip Code : 55455 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Minneapolis |
| City : Minneapolis |
| State : Minnesota |
| Zip Code : 55417 |
| Country : United States |
| Facility Name : CCOP - Kansas City |
| City : Kansas City |
| State : Missouri |
| Zip Code : 64131 |
| Country : United States |
| Facility Name : Ellis Fischel Cancer Center at University of Missouri - Columbia |
| City : Columbia |
| State : Missouri |
| Zip Code : 65203 |
| Country : United States |
| Facility Name : Missouri Baptist Cancer Center |
| City : Saint Louis |
| State : Missouri |
| Zip Code : 63131 |
| Country : United States |
| Facility Name : Siteman Cancer Center at Barnes-Jewish Hospital |
| City : Saint Louis |
| State : Missouri |
| Zip Code : 63110 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Columbia (Truman Memorial) |
| City : Columbia |
| State : Missouri |
| Zip Code : 65201 |
| Country : United States |
| Facility Name : UNMC Eppley Cancer Center at the University of Nebraska Medical Center |
| City : Omaha |
| State : Nebraska |
| Zip Code : 68198-7680 |
| Country : United States |
| Facility Name : CCOP - Southern Nevada Cancer Research Foundation |
| City : Las Vegas |
| State : Nevada |
| Zip Code : 89106 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Las Vegas |
| City : Las Vegas |
| State : Nevada |
| Zip Code : 89106 |
| Country : United States |
| Facility Name : New Hampshire Oncology-Hematology, PA - Hooksett |
| City : Hooksett |
| State : New Hampshire |
| Zip Code : 03106 |
| Country : United States |
| Facility Name : Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center |
| City : Lebanon |
| State : New Hampshire |
| Zip Code : 03756-0002 |
| Country : United States |
| Facility Name : Cancer Institute of New Jersey at the Cooper University Hospital |
| City : Camden |
| State : New Jersey |
| Zip Code : 08103 |
| Country : United States |
| Facility Name : CCOP - North Shore University Hospital |
| City : Manhasset |
| State : New York |
| Zip Code : 11030 |
| Country : United States |
| Facility Name : CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. |
| City : East Syracuse |
| State : New York |
| Zip Code : 13057 |
| Country : United States |
| Facility Name : Elmhurst Hospital Center |
| City : Elmhurst |
| State : New York |
| Zip Code : 11373 |
| Country : United States |
| Facility Name : Memorial Sloan-Kettering Cancer Center |
| City : New York |
| State : New York |
| Zip Code : 10021 |
| Country : United States |
| Facility Name : Mount Sinai Medical Center |
| City : New York |
| State : New York |
| Zip Code : 10029 |
| Country : United States |
| Facility Name : New York Weill Cornell Cancer Center at Cornell University |
| City : New York |
| State : New York |
| Zip Code : 10021 |
| Country : United States |
| Facility Name : North Shore University Hospital |
| City : Manhasset |
| State : New York |
| Zip Code : 11030 |
| Country : United States |
| Facility Name : Queens Cancer Center of Queens Hospital |
| City : Jamaica |
| State : New York |
| Zip Code : 11432 |
| Country : United States |
| Facility Name : Roswell Park Cancer Institute |
| City : Buffalo |
| State : New York |
| Zip Code : 14263-0001 |
| Country : United States |
| Facility Name : SUNY Upstate Medical University Hospital |
| City : Syracuse |
| State : New York |
| Zip Code : 13210 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Buffalo |
| City : Buffalo |
| State : New York |
| Zip Code : 14215 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Syracuse |
| City : Syracuse |
| State : New York |
| Zip Code : 13210 |
| Country : United States |
| Facility Name : Cape Fear Valley Medical Center |
| City : Fayetteville |
| State : North Carolina |
| Zip Code : 28302-2000 |
| Country : United States |
| Facility Name : CCOP - Southeast Cancer Control Consortium |
| City : Goldsboro |
| State : North Carolina |
| Zip Code : 27534-9479 |
| Country : United States |
| Facility Name : Comprehensive Cancer Center at Moore Regional Hospital |
| City : Pinehurst |
| State : North Carolina |
| Zip Code : 28374 |
| Country : United States |
| Facility Name : Comprehensive Cancer Center at Wake Forest University |
| City : Winston-Salem |
| State : North Carolina |
| Zip Code : 27157-1082 |
| Country : United States |
| Facility Name : Duke Comprehensive Cancer Center |
| City : Durham |
| State : North Carolina |
| Zip Code : 27710 |
| Country : United States |
| Facility Name : Lenoir Memorial Cancer Center |
| City : Kinston |
| State : North Carolina |
| Zip Code : 28503-1678 |
| Country : United States |
| Facility Name : Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill |
| City : Chapel Hill |
| State : North Carolina |
| Zip Code : 27599-7295 |
| Country : United States |
| Facility Name : NorthEast Oncology Associates - Concord |
| City : Concord |
| State : North Carolina |
| Zip Code : 28025 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Asheville |
| City : Asheville |
| State : North Carolina |
| Zip Code : 28805 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Durham |
| City : Durham |
| State : North Carolina |
| Zip Code : 27705 |
| Country : United States |
| Facility Name : Zimmer Cancer Center at New Hanover Regional Medical Center |
| City : Wilmington |
| State : North Carolina |
| Zip Code : 28402-9025 |
| Country : United States |
| Facility Name : Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University |
| City : Columbus |
| State : Ohio |
| Zip Code : 43210-1240 |
| Country : United States |
| Facility Name : Oklahoma University Medical Center |
| City : Oklahoma City |
| State : Oklahoma |
| Zip Code : 73104 |
| Country : United States |
| Facility Name : Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital |
| City : Pittsburgh |
| State : Pennsylvania |
| Zip Code : 15224 |
| Country : United States |
| Facility Name : Lifespan: The Miriam Hospital |
| City : Providence |
| State : Rhode Island |
| Zip Code : 02906 |
| Country : United States |
| Facility Name : Vermont Cancer Center at University of Vermont |
| City : Burlington |
| State : Vermont |
| Zip Code : 05401-3498 |
| Country : United States |
| Facility Name : Martha Jefferson Hospital |
| City : Charlottesville |
| State : Virginia |
| Zip Code : 22902 |
| Country : United States |
| Facility Name : MBCCOP - Massey Cancer Center |
| City : Richmond |
| State : Virginia |
| Zip Code : 23298-0037 |
| Country : United States |
| Facility Name : Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke |
| City : Roanoke |
| State : Virginia |
| Zip Code : 24014 |
| Country : United States |
| Facility Name : Virginia Oncology Associates - Norfolk |
| City : Norfolk |
| State : Virginia |
| Zip Code : 23502 |
| Country : United States |
| Facility Name : St. Mary's Medical Center |
| City : Huntington |
| State : West Virginia |
| Zip Code : 25701 |
| Country : United States |
| Interventions |
| Type : Drug |
| Name : celecoxib |
Search For Specialist
Types of Treatments
| Search Trials By |
| Research |
| Most Popular Trials |
| Library |
| Discuss |