Phase II study of pegylated liposomal doxorubicin (Caelyx™) as induction chemotherapy for patients with squamous cell cancer of the head and neck

Harrington, Kevin J.; Lewanski, Conrad; Northcote, A.D; Whittaker, J; Peters, A. M.; Vile, R. G.; Stewart, J.S.W.

doi:10.1016/s0959-8049(01)00216-7

Cited by 55 publications

(31 citation statements)

References 24 publications

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“…Liposomal drug delivery systems with doxorubicin have been extensively investigated in relapsed ovarian cancer (Muggia et al, 1997), breast cancer (Ranson et al, 1997) and others (Law et al, 1994;Schwartz and Caspar, 1995;Ellerhorst et al, 1999;Harrington et al, 2001;Judson et al, 2001). A number of trials have been performed with polymer -doxorubicin conjugate where there is covalent linkage of polymer to doxorubicin.…”

Section: Discussionmentioning

confidence: 99%

Phase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer

et al. 2004

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SP1049C is a novel anticancer agent containing doxorubicin and two nonionic pluronic block copolymers. In preclinical studies, SP1049C demonstrated increased efficacy compared to doxorubicin. The objectives of this first phase I study were to determine the toxicity profile, dose-limiting toxicity, maximum tolerated dose and pharmacokinetic profile of SP1049C, and to document any antitumour activity. The starting dose was 5 mg m À2 (doxorubicin content) as an intravenous infusion once every 3 weeks for up to six cycles. A total of 26 patients received 78 courses at seven dose levels. The dose-limiting toxicity was myelosuppression and DLT was reached at 90 mg m À2 . The maximum tolerated dose was 70 mg m À2 and is recommended for future trials. The pharmacokinetic profile of SP1049C showed a slower clearance than has been reported for conventional doxorubicin. Evidence of antitumour activity was seen in some patients with advanced resistant solid tumours. Phase II trials with this agent are now warranted to further define its antitumour activity and safety profile.

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Section: Discussionmentioning

confidence: 99%

Phase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer

et al. 2004

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“…In addition to the trials in ovarian cancer, single agent liposomal doxorubicin has been tested in breast cancer, (Ranson et al, 1997) soft tissue sarcoma (Judson et al, 2001) head and neck cancer (Harrington et al, 2001) melanoma (Ellerhorst et al, 1999) renal cell carcinoma (Law et al, 1994) and pancreatic carcinoma (Schwartz and Casper, 1995) Doxil has been studied in combination with other agents including docetaxel, (Malik et al, 1998;Drinkard et al, 1999;Hirsch et al, 1999) paclitaxel, (Israel et al, 1998;Langley et al, 1998;Moore et al, 1998;Woll et al, 1999) cisplatin, (Klein et al, 1999) vinorelbine (Burstein et al, 1999;Gebbia et al, 1999;Jahanzeb et al, 1999) and gemcitabine (Rivera et al, 2001). There have been no trials of doxil-carboplatin published.…”

Section: Discussionmentioning

confidence: 99%

A phase I dose-finding study of a combination of pegylated liposomal doxorubicin (Doxil), carboplatin and paclitaxel in ovarian cancer

et al. 2002

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Standard chemotherapy for advanced epithelial ovarian cancer is a combination of platinum-paclitaxel. One strategy to improve the outcome for patients is to add other agents to standard therapy. Doxil is active in relapsed disease and has a response rate of 25% in platinum-resistant relapsed disease. A dose finding study of doxil-carboplatin-paclitaxel was therefore undertaken in women receiving first-line therapy. Thirty-one women with epithelial ovarian cancer or mixed Mullerian tumours of the ovary were enrolled. The doses of carboplatin, paclitaxel and doxil were as follows: carboplatin AUC 5 and 6; paclitaxel, 135 and 175 mg m 72 ; doxil 20, 30, 40 and 50 mg m 72 . Schedules examined included treatment cycles of 21 and 28 days, and an alternating schedule of carboplatin-paclitaxel (q 21) with doxil being administered every other course (q 42). The dose-limiting toxicities were found to be neutropenia, stomatitis and palmar plantar syndrome and the maximum tolerated dose was defined as; carboplatin AUC 5, paclitaxel 175 mg m 72 and doxil 30 mg m 72 q 21. Reducing the paclitaxel dose to 135 mg m 72 did not allow the doxil dose to be increased. Delivering doxil on alternate cycles at doses of 40 and 50 mg m 72 also resulted in dose-limiting toxicities. The recommended doses for phase II/III trials are carboplatin AUC 6, paclitaxel 175 mg m 72 , doxil 30 mg m 72 q 28 or carboplatin AUC 5, paclitaxel 175 mg m 72 , doxil 20 mg m 72 q 21. Grade 3/4 haematologic toxicity was common at the recommended phase II doses but was short lived and not clinically important and non-haematologic toxicities were generally mild and consisted of nausea, paraesthesiae, stomatitis and palmar plantar syndrome.

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“…Preclinical and clinical HNSCC studies with liposomal doxorubicin have shown improved therapeutic effi cacy ( 14,15 ) and enhancement of the effects of radiation therapy ( 16 ).…”

Section: Animal and Tumor Modelmentioning

confidence: 99%

Chemoradionuclide Therapy with¹⁸⁶Re-labeled Liposomal Doxorubicin in Combination with Radiofrequency Ablation for Effective Treatment of Head and Neck Cancer in a Nude Rat Tumor Xenograft Model

et al. 2011

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Phase II study of pegylated liposomal doxorubicin (Caelyx™) as induction chemotherapy for patients with squamous cell cancer of the head and neck

Cited by 55 publications

References 24 publications

Phase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer

Phase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer

A phase I dose-finding study of a combination of pegylated liposomal doxorubicin (Doxil), carboplatin and paclitaxel in ovarian cancer

Chemoradionuclide Therapy with¹⁸⁶Re-labeled Liposomal Doxorubicin in Combination with Radiofrequency Ablation for Effective Treatment of Head and Neck Cancer in a Nude Rat Tumor Xenograft Model

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Phase II study of pegylated liposomal doxorubicin (Caelyx™) as induction chemotherapy for patients with squamous cell cancer of the head and neck

Cited by 55 publications

References 24 publications

Phase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer

Phase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer

A phase I dose-finding study of a combination of pegylated liposomal doxorubicin (Doxil), carboplatin and paclitaxel in ovarian cancer

Chemoradionuclide Therapy with186Re-labeled Liposomal Doxorubicin in Combination with Radiofrequency Ablation for Effective Treatment of Head and Neck Cancer in a Nude Rat Tumor Xenograft Model

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Chemoradionuclide Therapy with¹⁸⁶Re-labeled Liposomal Doxorubicin in Combination with Radiofrequency Ablation for Effective Treatment of Head and Neck Cancer in a Nude Rat Tumor Xenograft Model