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Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer

Primary Purpose

Breast Cancer, Colorectal Cancer, Pain

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Capecitabine
Celecoxib
Radiation Therapy
Placebo
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Hand-Foot Syndrome, cancer-related problem/condition, drug/agent toxicity by tissue/organ, pain, palmar-plantar erythrodysesthesia, stage IV breast cancer, male breast cancer, recurrent breast cancer, stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, Celecoxib, Celebrex, Capecitabine, Xeloda

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with metastatic colorectal cancer or breast cancer who are scheduled*** to receive capecitabine with an initial dose in the range of 750-1500 mg/m2** twice daily (total daily dose in the range of 1500-3000 mg/m2) alone or in combination with one or more other agents. ***Patients may enter the study after having received capecitabine for up to 21 days prior to study entry. **Doses may be rounded upward or downward per physician discretion to utilize 500mg tablets. Patients with either metastatic colorectal or metastatic breast cancer may have received any number or type of prior treatment regimens for metastatic disease or they may have received no prior treatment for metastatic disease. Men and women from all ethnic and racial groups. >/= 18 years old Eastern Cooperative Oncology Group (ECOG) Performance Status </= 2 Adequate organ function: a. Total bilirubin </= 1.5 * the institutional upper-normal limits (IUNL) b. aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) </= 2.5 * IUNL c. Patients with liver mets AST/(SGOT) and/or ALT(SGPT) < 5 * IUNL d. Alkaline phosphatase </= 5 * IUNL e. Creatinine Clearance > 50 ml/min Adequate bone marrow function: (a) Leukocytes >/= 3,000/microL; (b) Absolute neutrophil count >/= 1,500/microL; (c) Platelets >/= 100,000/microL Women of childbearing age and all men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Negative pregnancy test for women of childbearing age. Must have the ability to understand and the willingness to provide a written informed consent to participate in the study. Controlled brain metastasis (i.e. stereotactic surgery, surgery steroids, anticonvulsants). Exclusion Criteria: History of allergies to sulfonamide, aspirin, any NSAID (Nonsteroidal anti-inflammatory drugs)or 5FU or any COX-2 inhibitor. Any regular use of COX-2 inhibitors, NSAIDS or aspirin >325 mg more than twice a week. Pregnancy or lactation. History of significant neurological or psychiatric disorders that would impede giving consent, treatment or follow-up. Any serious illness or medical condition: uncontrolled congestive heart failure, uncontrolled hypertension or arrhythmia, active angina pectoris, any history of myocardial infarction, stroke or transient ischemic attack (TIA). Serious uncontrolled active infection. Patients who cannot comply with taking and documenting oral study medications. History of active peptic ulcer disease or upper gastrointestinal (GI) bleed within 12 months of enrollment. Use of warfarin. Patients with uncontrolled brain metastasis. Patients may have had prior Hand-foot syndrome (HFS) but it must be completely resolved for >/= 4 weeks. No concurrent radiation therapy.

Sites / Locations

  • CCOP - Santa Rosa Memorial Hospital
  • CCOP - Grand Rapids
  • CCOP - Kalamazoo
  • CCOP - Kansas City
  • Cancer Research for the Ozarks
  • Hematology Oncology Associates of Central New York, PC - Northeast Center
  • CCOP - Columbus
  • CCOP - Main Line Health
  • CCOP - Greenville
  • M. D. Anderson Cancer Center at University of Texas
  • Scott and White Cancer Institute
  • CCOP - Northwest
  • Marshfield Clinic - Marshfield Center
  • MBCCOP - San Juan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I: Celecoxib + Capecitabine

Arm II: Placebo + Capecitabine

Arm Description

Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).

Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day)

Outcomes

Primary Outcome Measures

Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on the CTC 3.0 Criteria.
The primary classification of palmar planter erythrodysethesia according to National Cancer Institute Common Toxicity Criteria (CTC) 3.0 criteria used to determine the incidences of > grade 1 hand and foot syndrome (HFS) by 16 weeks from the commencement of therapy.

Secondary Outcome Measures

Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on WHO Criteria.
A secondary classification of palmar planter erythrodysethesia according to World Health Organization (WHO) criteria will be used for determination of the incidences of > grade 1 HFS by 16 weeks from the commencement of therapy.

Full Information

First Posted
March 21, 2006
Last Updated
November 19, 2015
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI), Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00305643
Brief Title
Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer
Official Title
A Multicenter Phase III Placebo-Controlled Trial of Celecoxib for Prevention of Capecitabine-Induced Palmar/Plantar (Hand/Foot) Syndrome in Patients With Metastatic Breast and Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to low accrual. No data analyzed.
Study Start Date
February 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI), Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with capecitabine may kill more tumor cells. Celecoxib may prevent or lessen hand-foot syndrome caused by capecitabine. PURPOSE: This randomized phase III trial is studying how well celecoxib works in preventing hand/foot syndrome caused by capecitabine in patients with metastatic breast or colorectal cancer.
Detailed Description
OBJECTIVES: Determine the efficacy of celecoxib in reducing the incidence and severity of hand/foot syndrome caused by capecitabine in patients with metastatic breast cancer or colorectal cancer. OUTLINE: This is a placebo-controlled, randomized, double-blind, multicenter study. Patients are stratified according to metastatic disease (breast vs colorectal), ECOG performance status (0 or 1 vs 2), prior chemotherapy (yes vs no). Patients receive 1 of 2 treatment regimens. Regimen A (concurrent radiotherapy): Patients undergo radiotherapy 5 days a week for 5-6 weeks and receive oral capecitabine twice daily 5 days a week. Following completion of radiotherapy, patients may continue oral capecitabine as in regimen B. Regimen B (no radiotherapy): Patients receive oral capecitabine once daily on days 1-14. Courses repeat every 21 days. Patients are also randomized to 1 of 2 treatment arms. Arm I: Patients receive oral celecoxib twice daily on days 1-21. Arm II: Patients receive oral placebo twice daily on days 1-21. In both arms, treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 342 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Pain
Keywords
Hand-Foot Syndrome, cancer-related problem/condition, drug/agent toxicity by tissue/organ, pain, palmar-plantar erythrodysesthesia, stage IV breast cancer, male breast cancer, recurrent breast cancer, stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, Celecoxib, Celebrex, Capecitabine, Xeloda

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I: Celecoxib + Capecitabine
Arm Type
Experimental
Arm Description
Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
Arm Title
Arm II: Placebo + Capecitabine
Arm Type
Placebo Comparator
Arm Description
Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day)
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Initial dose of 750-1500 mg/m^2 orally twice a day for each 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
200 mg given orally twice a day for each 21 day cycle.
Intervention Type
Procedure
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
RT, XRT
Intervention Description
Some patients may undergo radiation therapy 5 days a week for 5-6 weeks, and receive oral capecitabine twice daily 5 days a week. Following completion of radiotherapy, patients may continue oral capecitabine once daily on days 1-14.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral placebo twice daily on days 1-21
Primary Outcome Measure Information:
Title
Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on the CTC 3.0 Criteria.
Description
The primary classification of palmar planter erythrodysethesia according to National Cancer Institute Common Toxicity Criteria (CTC) 3.0 criteria used to determine the incidences of > grade 1 hand and foot syndrome (HFS) by 16 weeks from the commencement of therapy.
Time Frame
At 16 Weeks, with evaluations and blood test every 3 weeks.
Secondary Outcome Measure Information:
Title
Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on WHO Criteria.
Description
A secondary classification of palmar planter erythrodysethesia according to World Health Organization (WHO) criteria will be used for determination of the incidences of > grade 1 HFS by 16 weeks from the commencement of therapy.
Time Frame
At 16 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with metastatic colorectal cancer or breast cancer who are scheduled*** to receive capecitabine with an initial dose in the range of 750-1500 mg/m2** twice daily (total daily dose in the range of 1500-3000 mg/m2) alone or in combination with one or more other agents. ***Patients may enter the study after having received capecitabine for up to 21 days prior to study entry. **Doses may be rounded upward or downward per physician discretion to utilize 500mg tablets. Patients with either metastatic colorectal or metastatic breast cancer may have received any number or type of prior treatment regimens for metastatic disease or they may have received no prior treatment for metastatic disease. Men and women from all ethnic and racial groups. >/= 18 years old Eastern Cooperative Oncology Group (ECOG) Performance Status </= 2 Adequate organ function: a. Total bilirubin </= 1.5 * the institutional upper-normal limits (IUNL) b. aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) </= 2.5 * IUNL c. Patients with liver mets AST/(SGOT) and/or ALT(SGPT) < 5 * IUNL d. Alkaline phosphatase </= 5 * IUNL e. Creatinine Clearance > 50 ml/min Adequate bone marrow function: (a) Leukocytes >/= 3,000/microL; (b) Absolute neutrophil count >/= 1,500/microL; (c) Platelets >/= 100,000/microL Women of childbearing age and all men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Negative pregnancy test for women of childbearing age. Must have the ability to understand and the willingness to provide a written informed consent to participate in the study. Controlled brain metastasis (i.e. stereotactic surgery, surgery steroids, anticonvulsants). Exclusion Criteria: History of allergies to sulfonamide, aspirin, any NSAID (Nonsteroidal anti-inflammatory drugs)or 5FU or any COX-2 inhibitor. Any regular use of COX-2 inhibitors, NSAIDS or aspirin >325 mg more than twice a week. Pregnancy or lactation. History of significant neurological or psychiatric disorders that would impede giving consent, treatment or follow-up. Any serious illness or medical condition: uncontrolled congestive heart failure, uncontrolled hypertension or arrhythmia, active angina pectoris, any history of myocardial infarction, stroke or transient ischemic attack (TIA). Serious uncontrolled active infection. Patients who cannot comply with taking and documenting oral study medications. History of active peptic ulcer disease or upper gastrointestinal (GI) bleed within 12 months of enrollment. Use of warfarin. Patients with uncontrolled brain metastasis. Patients may have had prior Hand-foot syndrome (HFS) but it must be completely resolved for >/= 4 weeks. No concurrent radiation therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Kopetz, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
CCOP - Santa Rosa Memorial Hospital
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hematology Oncology Associates of Central New York, PC - Northeast Center
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057-4510
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
CCOP - Main Line Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Scott and White Cancer Institute
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-0986
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
MBCCOP - San Juan
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
http://cancer.gov/clinicaltrials
Description
Clinical trial summary, the National Cancer Institute's PDQ® database
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

Learn more about this trial

Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer

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