Phase II trial of pegylated liposomal doxorubicin as consolidation chemotherapy in patients with stage III or IV ovarian or primary peritoneal carcinoma

Phase I/II Trial of External Irradiation plus Medium-Dose Brachytherapy Given Concurrently to Liposomal Doxorubicin and Cisplatin for Advanced Uterine Cervix Carcinoma

“…Despite the fact that there is no strong evidence supported by numerous published data suggesting that pegylated liposomal anthracyclines have direct antitumor effects in uterine cervix carcinoma, there are phase I/II studies [1,3,5,12,15,19,26,27,43,44] including the present trial which have shown that CCRT with Caelyx in uterine cervical carcinoma patients is a feasible approach during fractionated RT. Furthermore, it will be worthwhile to investigate the toxicity profile of the above regimen by increasing the weekly dose of CDDP up to 30-40 mg/m 2 according to the GOG standards.…”

“…The target Caelyx doses were 12-20 mg/m 2 /week with concomitant RT and CDDP [43,44], as well as 30-50 mg/m 2 given every 3-6 weeks, when administered alone [5,11,16,27] or combined with carboplatin [1,3,15,19].…”

“…In that way, one third of the injected dose is cleared from plasma into 3-4 h, the remaining being capable of circulating in the blood with a t 1/2 of 44-55 h; it is preferentially accumulated into the tumor environment with the free doxorubicin released, having both cytotoxic and radiosensitizing properties [37]. There are several studies examining the role of Caelyx given alone [5,11,16] or combined with CDDP and RT [43,44], docetaxel [21], carboplatin [1,3,15,19], and paclitaxel [12,26]. In previous phase I/II trials of CCRT regarding adenocarcinoma of the endometrium [44] and squamous cell carcinoma of the head/neck and lung [43], we found that the combination of CDDP and Caelyx administered concurrently with RT is well tolerated with sufficient activity to justify additional evaluation in clinical trials.…”

“…When Caelyx is used alone for treatment of advanced gynecologic malignancies, 30-50 mg/m 2 are infused over 1-2 h and administered every 4-6 weeks [5,11,16,27].…”