Double-blind randomized phase II study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: a report from the 11715 Study Group.
نویسندگان
چکیده
PURPOSE This phase II study evaluated the efficacy and safety of sorafenib plus dacarbazine in patients with advanced melanoma. PATIENTS AND METHODS This randomized, double-blind, placebo-controlled, multicenter study enrolled chemotherapy-naive patients with stage III (unresectable) or IV melanoma. A total of 101 patients received placebo plus dacarbazine (n = 50) or sorafenib plus dacarbazine (n = 51). On day 1 of a 21-day cycle, patients received intravenous dacarbazine 1,000 mg/m(2) for a maximum of 16 cycles. Oral sorafenib 400 mg or placebo was administered twice a day continuously. The primary end point was progression-free survival (PFS) by independent assessment. Secondary and tertiary end points included time to progression (TTP), response rate, and overall survival (OS). RESULTS Median PFS in the sorafenib plus dacarbazine arm was 21.1 weeks versus 11.7 weeks in the placebo plus dacarbazine arm (hazard ratio [HR], 0.665; P = .068). There were statistically significant improvements in PFS rates at 6 and 9 months, and in TTP (median, 21.1 v 11.7 weeks; HR, 0.619) in favor of the sorafenib plus dacarbazine arm. No difference in OS was observed (median, 51.3 v 45.6 weeks in the placebo plus dacarbazine and sorafenib plus dacarbazine arms, respectively; HR, 1.022). The regimen was well tolerated and had a manageable toxicity profile. CONCLUSION Sorafenib plus dacarbazine was well tolerated in patients with advanced melanoma and yielded an encouraging improvement in PFS. Based on these findings, additional studies with the combination are warranted in this patient population.
منابع مشابه
Minoxidil in combination with Tretinoin vs. Minoxidil in the treatment of male androgenic alopecia: A randomized, double-blind, parallel clinical trial
Background: Minoxidil is currently an approved treatment for androgenetic alopecia. Topical tretinoin can enhance skin absorption of minoxidil. Objective: This study has been done in order to determine the efficacy and safety of the solution of 0.5% minoxidil+0.05% tretinoin compared to 2% minoxidil in androgenetic alopecia in men. Patients and Methods: In a randomized, double-blind, parallel-g...
متن کاملEffects of Nigella sativa L. Seed Oil in Type II Diabetic Patients: a Randomized, Double-Blind, Placebo - Controlled Clinical Trial
Background: Nigella sativa (N. sativa) seeds are used to treat diabetes mellitus in traditional medicine. Moreover, N. sativa oil has reduced the fasting blood glucose level in non-diabetic volunteers. Objective: The present study was undertaken to explore the possible anti-hyperglycemic effect of N. sativa oil in type II diabetic patients. Methods: A randomized clinical trial was conducted ...
متن کاملA PROSPECTIV E, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL OF DEXAMETHASONE DURING THE FOLLICULAR PHASE IN CLOMIPHENE RESISTANT PATIENTS WITH POLYCYSTIC OVARY SYNDROME AND NORMAL DHEAS
In order to evaluate the effects of short course administration of dexamethasone (DEX) combined with clomiphene citrate (CC) in CC-resistant patients with polycystic ovary syndrome (PCaS) and normal DHEAS, a prospective, double blind, placebo controlled, randomized study was undertaken at referral university hospitals, Two-hundred and thirty women with PCOS and normal DHEAS who failed to ...
متن کاملAdministration of Iranian Propolis attenuates oxidative stress and blood glucose in type II diabetic patients: a randomized, double-blind, placebo-controlled, clinical trial
Background: Hyperglycemia in diabetic people resulted in oxidative conditions. Propolis is the third most important component of bee products which has various functional properties such as anti-oxidant due to its components. The aim of this study was to evaluate the propolis effect on fructosamine level, the catalase activity, and the level of oxidized LDL changes in type 2 diabetic patients. ...
متن کاملTopical Channa striatus 5% cream for inflammatory skin conditions: A phase I randomized double-blind, controlled trial
Background: Channa striatus or better known as the haruan fish is an indigenous, snakehead, striped, air breathing freshwater fish of Malaysia and has long been consumed traditionally during post-operative and post-partum period to speed recovery. Most medical properties of the haruan are contributed to its high content of essential fatty and amino acids. This was a phase I clinical trial to ex...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
دوره 26 13 شماره
صفحات -
تاریخ انتشار 2008