- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00418028
Standard Versus Continuous Capecitabine in Advanced Breast Cancer
Randomized Phase II Trial of Continuous Versus Standard Capecitabine in Advanced Breast Cancer.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Madrid, Spain, 28040
- Hospital Clinico San Carlos
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Patients diagnosed with metastatic breast cancer
- Patients that either have received previous treatment with anthracyclines and/or taxanes or not (either as advance or in metastatic disease).
- The patient is ambulatory with a functional ECOG < 2 status (see Appendix 2).
- Patient presents, at least one lesion measurable according to RECIST criteria (see Appendix 3)
- Patients with a life expectancy of at least 3 months.
- Patients that agree to and are able to fulfill the requirements of the whole protocol through the whole study.
Exclusion criteria:
- Patients that have previously shown unexpected severe reactions to therapy with fluoropyrimidines or with a known sensitivity to 5-fluorouracile.
- Patients previously treated with capecitabine.
- Patients with organ transplants.
Other diseases or severe affections:
- Patients with previous convulsions, central nervous system diseases or psychiatric diseases, including dementia, that the investigator might consider clinically significant and which adversely affect therapeutic compliance.
- Patients with severe intellectual impairment, unable to carry out basic daily routines and established depression.
- Clinical significant cardiac disease (e. g. . congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not fully controlled with medication) or myocardial infarction within the last 12 months.
- Severe renal impairment (baseline creatinine clearance < 30 ml/min)
- Patients with signs of metastasis in the CNS. Patients with a history of uncontrolled convulsions, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded.
- Patients with an active infection.
- Patients with a history of other neoplasias during the previous five years, except for basal cell skin cancer or cervical cancer in situ, both cured.
Patients showing the following laboratory values:
- Neutrophil count < 555 x 109/l
- Platelet count< 100 x 109/l
- Serum creatinine > 1,5 x upper normality limit
- seric bilirubin > 2,0 x upper normality limit
- ALAT, ASAT > 2,5 x upper normality limit or > 5 x upper normality limit in case of liver metastases
- Alkaline phosphatase > 2,5 x upper normality limit > 5 x upper normality limit in case of liver metastases o > 10 x upper normality limit in case of bone metastases.
- Patients under radiotherapy four weeks prior to the initiation of the study treatment, or under previous radiotherapy on the marker lesions be measured during the study (new marker lesions that appear in previously irradiated areas are accepted) or patients who are receiving programmed radiotherapy.
- Patients under major surgery within 4 weeks prior to study treatment or who have not completely recovered from the effects of major surgery.
- Patients who lack upper gastrointestinal tract physical integrity or with malabsorption syndrome.
- Patients who have received more than two cycles of chemotherapy for the metastatic disease.
- Patients Her2 + per FISH ó +++ Immunohistochemistry
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: A Cint
Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
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Other Names:
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Experimental: B Ccont
Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Progression
Time Frame: After 1 year from the treatment start day.
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Time to Progression (TTP) is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease.
That is, a patient has an event is she progresses or dies due to progressive disease.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).
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After 1 year from the treatment start day.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: Through the study treatment, an average of 5 months.
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Response was evaluated using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), every 3 cycles of chemotherapy (each cycle lasts 3 weeks) and at the end of treatment (at 21 weeks from the start of treatment).
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Through the study treatment, an average of 5 months.
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Response Duration
Time Frame: Time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first, assessed up to 72 weeks.
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Response duration is computed for all patients with Partial Response or Complete Response, during the treatment period, as the time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first. A patient is censored if she does not progress or die. In these cases Response duration is computed as the time from the moment the Partial or Complete Response is reported to the last contact date. |
Time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first, assessed up to 72 weeks.
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Time to Treatment Failure
Time Frame: Time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient's decision or investigator criteria, assessed up to 72 months.
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Time to treatment failure (TTF) is defined as the time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient's decision or investigator criteria. If a patient did not end the treatment, it is censored. The censoring date is the date of the last dose received. |
Time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient's decision or investigator criteria, assessed up to 72 months.
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Overall Survival
Time Frame: Time to survival is the number of months from the study treatment start date to the date of death, assessed up to 100 months.
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An event is defined as death.
A patient is censored if she does not die.
The censoring date is last contact date.
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Time to survival is the number of months from the study treatment start date to the date of death, assessed up to 100 months.
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Clinical Benefit
Time Frame: Months from "CR","PR" or "SD" (the first one) until Progression date, new treatment or last contact date.
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A patient experiences a Clinical Benefit if the following is satisfied: Criterion: The patient has "Complete response", "Partial Response" or "Stable Disease" and it continues during more than 3 months. |
Months from "CR","PR" or "SD" (the first one) until Progression date, new treatment or last contact date.
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Progression Free Survival
Time Frame: Time (in months) from the moment the patient starts the study treatment to the date of progressive disease assessed up to 84 months.
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Progression Free Survival is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease.
That is, a patient has an event is she progresses or dies for any reason.
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Time (in months) from the moment the patient starts the study treatment to the date of progressive disease assessed up to 84 months.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Miguel Martin, MD,PhD, Hospital Clinico San Carlos
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/237
- 2004-002759-15 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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