Xeloda scientific update |
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Br J Cancer. 2005 Mar 14;92(5):820-6.
Delord JP, Pierga JY, Dieras V, Bertheault-Cvitkovic F, Turpin FL, Lokiec F, Lochon I, Chatelut E, Canal P, Guimbaud R, Mery-Mignard D, Cornen X, Mouri Z, Bugat R.
1Institut Claudius Regaud, 20-24, rue du Pont Saint Pierre, Toulouse 31052, France.
A phase I clinical and pharmacokinetic study of capecitabine (Xeloda((R))) and irinotecan combination therapy (XELIRI) in patients with metastatic gastrointestinal tumours.
A study on a combination therapy using capecitabine (Xeloda((R))) and irinotecan) in patients with metastatic gastrointestinal tumours. Around 27 patients with gastrointestinal tumours participated in this phase I clinical and pharmacokinetic study. At the end of the study it was found that the combination was clinically active.
Capecitabine is a highly active oral fluoropyrimidine that is an attractive alternative to 5-fluorouracil in colorectal cancer treatment. The current study, undertaken in 27 patients with gastrointestinal tumours, aimed to assess the toxicity and potential for significant pharmacokinetic interactions of a combination regimen incorporating capecitabine with 3-weekly irinotecan (XELIRI). Irinotecan (200 and 250 mg m(-2)) was administered as a 90-min infusion on day 1 in combination with escalating capecitabine doses (700-1250 mg m(-2) twice daily) administered on days 2-15 of a 3-week treatment cycle. Pharmacokinetics were characterised on days 1 and 2 of the first two cycles. A total of 103 treatment cycles were administered. The principal dose-limiting toxicities were diarrhoea and neutropenia. Capecitabine 1150 mg m(-2) twice daily with irinotecan 250 mg m(-2) was identified as the maximum-tolerated dose and capecitabine 1000 mg m(-2) with irinotecan 250 mg m(-2) was identified as the recommended dose for further study. Analyses confirmed that there were no significant pharmacokinetic interactions between the two agents. The combination was clinically active, with complete and partial responses achieved in heavily pretreated patients. This study indicates that XELIRI is a potentially feasible and clinically active regimen in patients with advanced gastrointestinal cancer.British Journal of Cancer (2005) 92, 820-826. doi:10.1038/sj.bjc.6602354 www.bjcancer.com Published online 1 March 2005.
Zhonghua Zhong Liu Za Zhi. 2004 Dec;26(12):746-8.
Qian J, Qin SK, Mei JF, Chen YX, Shao ZJ, He ZM.
Department of Medical Oncology, PLA Oncology Center, 81st Hospital, Nanjing 210002, China.
[Oxaliplatin plus capecitabine as a second line chemotherapy for patients with advanced gastric cancer.]
Here the author reports the effect of a combination of oxaliplatin and capecitabine as a second line chemotherapy for patients with advanced gastric cancer. The combination of oxaliplatin and capecitabine was found effective after the research. More detailed studies are required on this area to find out all the facts.
OBJECTIVE: To evaluate the effect and toxicity of oxaliplatin combined with capecitabine (Xeloda) as a second-line chemotherapy regimen for patients with advanced gastric cancer. METHODS: Twenty-four patients with advanced gastric cancer who had been treated by multiple chemotherapy regimens presenting poor responses were allotted. LX regimen (oxaliplatin 85 mg/m(2) in 2-hour infusion on D1 and D15, capecitabine 1250 mg/m(2)/d divided in two daily doses given from D1 to D14) was adopted. The cycles were repeated every 28 days. All patients received two or more cycles. RESULTS: All 24 patients were evaluated after having received 2 to 6 cycles of chemotherapy, totally 92 cycles. The overall response rate was 29.2% (including 2 CR, 5 PR, 10 NC and 7 PD). The time to tumor progression (TTP) was 2 to 18 months (median 5 months), and duration of remission was 4 to 14 months (median 8 months). The major toxicities were bone marrow suppression and nausea/vomiting. CONCLUSION: Oxaliplatin combined with capitabine is effective as a secondary line regimen for patients with advanced gastric cancer. This protocol is active and well tolerated. Further clinical studies are warranted.
Clin Cancer Res. 2005 Mar 1;11(5):1870-6.
Kindwall-Keller T, Otterson GA, Young D, Neki A, Criswell T, Nuovo G, Soong R, Diasio R, Villalona-Calero MA.
Division of Hematology/Oncology, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.
Phase II Evaluation of Docetaxel-Modulated Capecitabine in Previously Treated Patients with Non-Small Cell Lung Cancer.
A second phase evaluation in previously treated non-small cell lung cancer patients using docetaxel and modulated capecitabine. This second phase study is for patients with refractory or relapsed non-small cell lung cancer. The combination of capecitabine and weekly docetaxel is effective for patients with non-small cell lung cancer.
PURPOSE: Based on the preclinical observation of upregulation of thymidine phosphorylase, the last enzymatic step in the conversion of capecitabine to 5-fluorouracil, by docetaxel along with good clinical tolerability of the combination of docetaxel and capecitabine using an optimized schedule in a previous phase I trial, we conducted this phase II study of this combination in patients with refractory or relapsed non-small cell lung cancer (NSCLC).Patients and Methods: Patients with NSCLC previously treated with at least one platinum- or paclitaxel-based regimen received docetaxel 36 mg/m(2) on days 1, 8, and 15 and capecitabine 625 mg/m(2) twice daily on days 5 to 18, every 4 weeks. The primary objective of the study was evaluation of progression-free survival (PFS) 26 weeks from initiation of treatment.RESULTS: Thirty-six evaluable patients received 104 cycles of the combination. Severe toxicities were infrequent with only one patient requiring toxicity-related hospitalization. The 26-week PFS rate was 25% (95% confidence interval, 12-42) with an intent to treat median survival and 1-year survival rate of 9.1 months and 37%, respectively. Among 31 patients with measurable disease (Response Evaluation Criteria in Solid Tumors criteria), eight (26%; 95% confidence interval, 12-45) achieved partial responses.CONCLUSION: The combination of capecitabine and weekly docetaxel is well tolerated in previously treated patients with NSCLC. The relatively high 26-week PFS and 1-year survival, as well as the high response rate observed, encourages further evaluation of this regimen in NSCLC, either in randomized trials for refractory patients or as a potential treatment option for chemotherapy naive patients.
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Drug category:Anti-cancer drugs
 Xeloda scientific update
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