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Trial record 1 of 1 for:    NCT00305643
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Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00305643
Recruitment Status : Terminated (Terminated due to low accrual. No data analyzed.)
First Posted : March 22, 2006
Results First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE March 21, 2006
First Posted Date  ICMJE March 22, 2006
Results First Submitted Date  ICMJE January 25, 2012
Results First Posted Date  ICMJE December 24, 2015
Last Update Posted Date December 24, 2015
Study Start Date  ICMJE February 2006
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on the CTC 3.0 Criteria. [ Time Frame: At 16 Weeks, with evaluations and blood test every 3 weeks. ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on WHO Criteria. [ Time Frame: At 16 Weeks ]
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Colorectal Cancer
  • Pain
Intervention  ICMJE
  • Drug: Capecitabine
    Initial dose of 750-1500 mg/m^2 orally twice a day for each 21 day cycle.
    Other Name: Xeloda
  • Drug: Celecoxib
    200 mg given orally twice a day for each 21 day cycle.
    Other Name: Celebrex
  • Procedure: Radiation Therapy
    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.
    Other Names:
    • RT
    • XRT
  • Drug: Placebo
    Oral placebo twice daily on days 1-21
Study Arms  ICMJE
  • Experimental: Arm I: Celecoxib + Capecitabine
    Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
    Interventions:
    • Drug: Capecitabine
    • Drug: Celecoxib
    • Procedure: Radiation Therapy
  • Placebo Comparator: Arm II: Placebo + Capecitabine
    Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day)
    Interventions:
    • Drug: Capecitabine
    • Procedure: Radiation Therapy
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 4, 2009)
11
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Men and women from all ethnic and racial groups.
  4. >/= 18 years old
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status </= 2
  6. 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
  7. Adequate bone marrow function: (a) Leukocytes >/= 3,000/microL; (b) Absolute neutrophil count >/= 1,500/microL; (c) Platelets >/= 100,000/microL
  8. 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.
  9. Negative pregnancy test for women of childbearing age.
  10. Must have the ability to understand and the willingness to provide a written informed consent to participate in the study.
  11. Controlled brain metastasis (i.e. stereotactic surgery, surgery steroids, anticonvulsants).

Exclusion Criteria:

  1. History of allergies to sulfonamide, aspirin, any NSAID (Nonsteroidal anti-inflammatory drugs)or 5FU or any COX-2 inhibitor.
  2. Any regular use of COX-2 inhibitors, NSAIDS or aspirin >325 mg more than twice a week.
  3. Pregnancy or lactation.
  4. History of significant neurological or psychiatric disorders that would impede giving consent, treatment or follow-up.
  5. 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).
  6. Serious uncontrolled active infection.
  7. Patients who cannot comply with taking and documenting oral study medications.
  8. History of active peptic ulcer disease or upper gastrointestinal (GI) bleed within 12 months of enrollment.
  9. Use of warfarin.
  10. Patients with uncontrolled brain metastasis.
  11. Patients may have had prior Hand-foot syndrome (HFS) but it must be completely resolved for >/= 4 weeks.
  12. No concurrent radiation therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00305643
Other Study ID Numbers  ICMJE 2005-0328
MDA-CCC-0326 ( Other Identifier: NCI )
MDA-2005-0328 ( Other Identifier: NCI )
CDR0000458042 ( Registry Identifier: NCI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Pfizer
Investigators  ICMJE
Principal Investigator: Scott Kopetz, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP