Clinical trial · Interventional
Capecitabine in Metastatic Breast and GI Cancers
Randomized Open-label Trial of Dose Dense, Fixed Dose Capecitabine Compared to Standard Dose Capecitabine in Metastatic Breast Cancer and Advanced/Metastatic Gastrointestinal Cancers.
NCT02595320CI-TRIAL-00055592X7-7unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is compare different doses of capecitabine to see if one is better than the other in terms of efficacy and toxicity.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- capecitabine, 1500 mg, twice a day for 7 days on then 7 days off
- interventionNames
- Drug: Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- Group B
- description
- capecitabine, 1250 mg/m2 OR 1000 mg/m2, twice a day for 14 days on then 7 days off
- interventionNames
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Twelve-week Progression Free Survival (cohort 1 only)
- timeFrame
- 12 weeks from the date of registration into the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with metastatic breast cancer OR men and women with metastatic gastrointestinal (GI) cancer * There is no limit to the number of prior chemotherapy or endocrine therapy regimens received. Use of a previous fluoropyrimidine-containing regimen in advanced / metastatic setting is permitted as long as the subject discontinued the regimen for reasons other than progression. * No restriction on the use of fluoropyrimidine-containing regimen in the neoadjuvant or adjuvant setting * For metastatic colorectal cancers, patients starting maintenance capecitabine after a course of oxaliplatin or irinotecan based chemotherapy are eligible. * Measurable or non-measurable disease per RECIST criteria 1.1 * Must have completed prior chemotherapy or radiation therapy at least 2 weeks prior to registration * Pathologic confirmation of respective malignancies. Biopsy of metastatic disease is preferred but not mandatory. * Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 0-2 * Adequate organ and marrow function as defined below: * Absolute neutrophil count ≥ 1,000/ microLiter (uL) * hemoglobin ≥ 7 g/L * platelets ≥ 50,000/uL * total bilirubin ≤ 2 X the Institutional Upper Limit of Normal (IULN) * o Aspartate Aminotransferase (AST) ( Serum Glutamic Oxaloacetic Transaminase \[SGOT\]) ≤ 5 X IULN * Alanine Aminotransferase (ALT) (Serum Pyruvic Glutamic Transaminase \[SPGT\]) ≤ 5 X IULN * creatinine clearance \> 50 milliliters per minute (ml/min) * Women of childbearing potential must agree to use adequate contraception. * Subjects may have previously treated brain or Central Nervous System (CNS) metastasis with radiation completed at least 2 weeks prior to registration. Prior radiation to places other than CNS disease must be completed at least 14 days prior to registration. Any number of prior radiation therapy regimens is allowed provided all toxicity of prior therapy is resolved to grade 1 or less. * Life expectancy of \>3 months Exclusion Criteria: * Patient has used Capecitabine in a past regimen for metastatic disease. * Patient is currently using, or planning to use another investigational agent. * Patient with known Dihydropyrimidine Dehydrogenase (DPD) deficiency * Patient has symptomatic brain or CNS metastases. * Patient has leptomeningeal disease * Patient is pregnant or nursing * Subjects must have no barriers to taking oral medications, for example uncontrolled nausea, vomiting, diarrhea at baseline, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome. * No recent (≤ 3months) of partial or complete bowel obstruction unless surgically corrected.
References
Publications (32)
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- BACKGROUNDHofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Muller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. doi: 10.1016/S1470-2045(12)70116-X. Epub 2012 Apr 13. PMID 22503032
- BACKGROUNDKopf B, De Giorgi U, Zago S, Carminati O, Rosti G, Marangolo M. Innovative therapy for patients with brain metastases: oral treatments. J Chemother. 2004 Nov;16 Suppl 5:94-7. doi: 10.1080/1120009x.2004.11782396. PMID 15675490
- BACKGROUNDFumoleau P, Largillier R, Clippe C, Dieras V, Orfeuvre H, Lesimple T, Culine S, Audhuy B, Serin D, Cure H, Vuillemin E, Morere JF, Montestruc F, Mouri Z, Namer M. Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer. 2004 Mar;40(4):536-42. doi: 10.1016/j.ejca.2003.11.007. PMID 14962720
- BACKGROUNDOshaughnessy JA, Blum J, Moiseyenko V, Jones SE, Miles D, Bell D, Rosso R, Mauriac L, Osterwalder B, Burger HU, Laws S. Randomized, open-label, phase II trial of oral capecitabine (Xeloda) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol. 2001 Sep;12(9):1247-54. doi: 10.1023/a:1012281104865.