Breast CancerPhase 3NCT00305643
Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer
A Phase 3 study testing Capecitabine, Celecoxib and Radiation Therapy in people with Breast Cancer and Colorectal Cancer, run by M.D. Anderson Cancer Center at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Pain
- What is being tested?
- Capecitabine, Celecoxib and Radiation Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Feb 2006to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
CCOP - Columbus
Columbus, Ohio, 43215
Hematology Oncology Associates of Central New York, PC - Northeast Center
East Syracuse, New York, 13057-4510
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
CCOP - Greenville
Greenville, South Carolina, 29615
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Kansas City
Kansas City, Missouri, 64131
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
Cancer Research for the Ozarks
Springfield, Missouri, 65804
CCOP - Northwest
Tacoma, Washington, 98405-0986
Scott and White Cancer Institute
Temple, Texas, 76508
CCOP - Main Line Health
Wynnewood, Pennsylvania, 19096
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Colorectal Cancer, Pain
- Being tested
- Capecitabine, Celecoxib, Radiation Therapy, Placebo
- 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
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Pain, Hand-Foot Syndrome, Drug-Related Side Effects and Adverse Reactions, Breast Neoplasms, Male, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
Initial dose of 750-1500 mg/m^2 orally twice a day for each 21 day cycle.
CelecoxibDrug
Also called Celebrex
200 mg given orally twice a day for each 21 day cycle.
Radiation TherapyProcedure or surgery
Also called RT, XRT
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.
PlaceboDrug
Oral placebo twice daily on days 1-21
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Celecoxib + Capecitabine | Experimental | Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day). Receives: Drug: Capecitabine; Drug: Celecoxib; Procedure: Radiation Therapy |
| Arm II: Placebo + Capecitabine | Placebo comparator | Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day) Receives: Drug: Capecitabine; Procedure: Radiation Therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 16 Weeks, with evaluations and blood test every 3 weeks.
Secondary outcomes (1)
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.
Measured: At 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Terminated due to low accrual. No data analyzed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pfizer
- Responsible party
- Sponsor
- Investigators
- Scott Kopetz, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305643
- Sponsor's protocol ID
- 2005-0328
- Other IDs
- MDA-CCC-0326, MDA-2005-0328, CDR0000458042
- Status last verified
- Nov 2015
- First submitted
- 21 Mar 2006
- Last updated
- 24 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00305643
- Acronym / sponsor ID
- 2005-0328
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low accrual. No data analyzed.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pfizer
- Study start
- Feb 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Mar 2006 (estimated)
- Results
- Posted 24 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: Celecoxib + Capecitabine | Experimental | Drug: Capecitabine, Drug: Celecoxib, Procedure: Radiation TherapyCelecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day). |
| Arm II: Placebo + Capecitabine | Placebo comparator | Drug: Capecitabine, Procedure: Radiation Therapy, Drug: PlaceboPlacebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: XelodaInitial dose of 750-1500 mg/m^2 orally twice a day for each 21 day cycle. | Drug | Arm I: Celecoxib + Capecitabine, Arm II: Placebo + Capecitabine |
| CelecoxibAlso: Celebrex200 mg given orally twice a day for each 21 day cycle. | Drug | Arm I: Celecoxib + Capecitabine |
| Radiation TherapyAlso: RT, XRTSome 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. | Procedure or surgery | Arm I: Celecoxib + Capecitabine, Arm II: Placebo + Capecitabine |
| PlaceboOral placebo twice daily on days 1-21 | Drug | Arm II: Placebo + Capecitabine |
Primary outcome
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.
1 secondary outcome
Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on WHO Criteria.
Time frame: At 16 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical trial summary, the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Kopetz, MD principal investigator
M.D. Anderson Cancer Center
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine, Celecoxib and Radiation Therapy in people with Breast Cancer and Colorectal Cancer, run by M.D. Anderson Cancer Center at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.