Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Color… (NCT00305643) | Clinical Trial Compass
TerminatedPhase 3
Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer
Stopped: Terminated due to low accrual. No data analyzed.
United States, Puerto Rico11 participantsStarted 2006-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on the CTC 3.0 Criteria.
Timeframe: At 16 Weeks, with evaluations and blood test every 3 weeks.
. 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
. 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.
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.