Capecitabine and Oxaliplatin in Treating Patients With Metastatic Breast Cancer
Kľúčové slová
Abstrakt
Popis
OUTLINE: This is a multi-center study.
CAPOX (21 day cycle):
- Capecitabine 825 mg/m2 orally twice daily Days 1-14.
- Oxaliplatin 100 mg/m2 intravenously Day 1
Patients may continue combination therapy until progression or toxicity intervenes. Patients who discontinue either agent due to toxicity may, at the investigators discretion, continue therapy with the remaining single agent on study.
ECOG performance status 0 or 1
Hematopoietic:·
- ANC > 1,200/mm3·
- Platelets > 100,000/mm3
Hepatic:·
- Total bilirubin < 1.5 x ULN·
- AST < 2 x ULN (up to 5 x ULN in patients with known liver involvement)
Renal:·
- Serum creatinine < 1.5 x ULN and estimated creatinine clearance >50ml/min as calculated with Cockroft-Gault equation
Cardiovascular:·
- No clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
Termíny
| Naposledy overené: | 11/30/2015 |
| Prvý príspevok: | 09/08/2005 |
| Odhadovaná registrácia bola odoslaná: | 09/13/2005 |
| Prvý príspevok: | 09/21/2005 |
| Posledná aktualizácia bola odoslaná: | 12/07/2015 |
| Posledná aktualizácia bola zverejnená: | 12/08/2015 |
| Aktuálny dátum začatia štúdie: | 02/29/2004 |
| Odhadovaný dátum dokončenia primárneho okruhu: | 05/31/2007 |
| Odhadovaný dátum dokončenia štúdie: | 05/31/2007 |
Stav alebo choroba
Intervencia / liečba
Drug: Single Group Assignment
Drug: Single Group Assignment
Fáza
Skupiny zbraní
| Arm | Intervencia / liečba |
|---|---|
| Experimental: Single Group Assignment Capecitabine + Oxaliplatin | Drug: Single Group Assignment Capecitabine 825 mg/m2 po bid, days 1-14 |
Kritériá oprávnenosti
| Vek vhodný na štúdium | 18 Years To 18 Years |
| Pohlavia vhodné na štúdium | Female |
| Prijíma zdravých dobrovoľníkov | Áno |
| Kritériá | Inclusion Criteria: - Histologic or cytologic diagnosis of breast cancer with evidence of (1) unresectable, locally recurrent, or (2) metastatic disease.· - Patients with HER2 positive (3+ overexpression by IHC or gene amplification by FISH) are eligible only if they have had prior trastuzumab therapy.· - At least one measurable lesion as defined by the RECIST. - Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease. Exclusion Criteria: - No prior therapy with capecitabine or oxaliplatin in any setting - No prior therapy with other platinum compounds· - No other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to beginning protocol therapy.· - No prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.· - No prior fluoropyrimidine therapy for metastatic disease is allowed. Prior adjuvant fluoropyrimidine therapy is allowed if completed > 12 months from study entry.· - Maximum of one prior chemotherapy regimen for unresectable, locally recurrent or metastatic disease· - No symptomatic brain metastasis. · - No evidence of serious concomitant systemic disorders incompatible with the study · - No peripheral neuropathy · - No major surgery within 28 days prior to beginning protocol therapy.· - Negative pregnancy test· - No female patients currently breastfeeding· - No malabsorption syndrome· - No evidence of serious concomitant systemic disorders incompatible with the study· - Patients must not be treated with any of the following while on protocol therapy or within 28 days prior to beginning protocol therapy: sorivudine, brivudine, cimetidine, allopurinol. |
Výsledok
Primárne výstupné opatrenia
1. - To determine the objective response rate (CR+PR) of capecitabine and oxaliplatin (CAPOX) in patients with metastatic breast cancer. [36 months]
Opatrenia sekundárnych výsledkov
1. To measure time to progression · [36 months]
2. To determine rate of clinical benefit response (CR + PR + SD > 6 months). · [36 months]
3. To determine toxicity rate of CAPOX in this patient population.· [36 months]
4. To explore potential correlations between thymidine synthase (TS), thymidine phosphorylase (TP) and dihydropyrimidine dehydrogenase (DPD) expression in the primary tumor with response. [36 months]
