A phase I trial of 96-hour padlitaxel infusion plus accelerated radiotherapy of unrespectable head and neck cancer

Machtay, Mitchell; Aviles, V.; Kligerman, Morton M.; Treat, Joseph; Weinstein, Gregory S.; Weber, Randal S.; Mirza, Natasha; Chalian, Ara A.; Rosenthal, David I.

doi:10.1016/s0360-3016(99)00027-9

Cited by 15 publications

(9 citation statements)

References 11 publications

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“…20 A completed Phase I study using a 96-hour continuous infusion delivery of paclitaxel given during Weeks 1 and 5 of radiation with a modified, concomitant boost radiation schedule had an MTD of 100 mg/m 2 and DLTs of skin toxicity, mucositis, and febrile neutropenia. 19 Eight patients achieved a CR, 4 patients achieved a PR, and 1 patient had PD among 13 patients who were treated, with all patients experiencing reversible Grade 3 toxicity. Plasswilm et al employed a unique, split-course/twice-daily radiation schedule with concurrent paclitaxel delivered during Weeks 1 and 5 at a dose of 30 mg/m 2 per day for a total of 5 days.…”

Section: Discussionmentioning

confidence: 95%

A Phase I/II trial of concurrent docetaxel and radiation after induction chemotherapy in patients with poor prognosis squamous cell carcinoma of the head and neck

Tishler

Norris

Colevas

et al. 2002

Cancer

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BACKGROUNDThe authors conducted a Phase I/II study in patients with a poor prognosis who had locally advanced squamous cell carcinoma of the head and neck (SCCHN) and who were treated initially with induction chemotherapy. Patients were treated with weekly docetaxel and concurrent daily fractionated radiation therapy to determine the maximum tolerated dose (MTD) of docetaxel and the efficacy of the regimen.METHODSTwenty‐two patients were enrolled, and 21 patients were treated. Eight patients had Stage III SCCHN, and 13 patients had Stage IV SCCHN without distant metastases and were treated first with 2‐3 cycles of induction chemotherapy, which consisted of cisplatin plus 5‐fluorouracil with or without leucovorin. Patients with a poor prognosis were identified as those who achieved a partial response to induction treatment, achieved a complete response with a positive biopsy, or were at high risk for developing recurrent disease. Patients were treated subsequently with concurrent, escalating doses of docetaxel (given weekly × 6) and once daily 200‐centigray radiation fractions.RESULTSThree patients were treated with a weekly docetaxel dose of 20 mg/m2 without dose‐limiting toxicity (DLT). Both patients who were treated at the next dose level of 30 mg/m2 experienced DLT. A dose of 25 mg/m2 was studied without DLT in the 16 patients who were treated, establishing this as the MTD. Sixty‐seven percent of the patients are alive without disease at a median follow‐up of 35 months (range, 12–59 months) after the initiation of chemoradiotherapy.CONCLUSIONSThe MTD of weekly docetaxel with concurrent daily radiation therapy in the postinduction setting was 25 mg/m2. Disease free survival data from this study were good and indicated that this regimen was effective in the treatment of patients with SCCHN who had a poor prognosis. Cancer 2002;95:1472–81. © 2002 American Cancer Society.DOI 10.1002/cncr.10873

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Section: Discussionmentioning

confidence: 95%

A Phase I/II trial of concurrent docetaxel and radiation after induction chemotherapy in patients with poor prognosis squamous cell carcinoma of the head and neck

Tishler

Norris

Colevas

et al. 2002

Cancer

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“…The MACH-NC meta-analysis did not reveal a survival advantage of additional 5-FU to platinum-based concurrent radiochemotherapy [17]. Paclitaxel -as "second generation" chemotherapy agent -has shown antitumor efficacy when used in phase I and II concomitant radiochemotherapy protocols with acceptable toxicity [7,11,16,24]. The combination of platinum and paclitaxel has been tested by several groups in phase II studies.…”

Section: Discussionmentioning

confidence: 99%

Definitive radiochemotherapy of advanced head and neck cancer with carboplatin and paclitaxel

et al. 2011

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“…So far, nine phase I/II trials with sRCT including paclitaxel in tumors of the head and neck have been published (Table 4) [5,8,19,23,28,[31][32][33][34]. The treatment schedules were different, but all studies showed a nearly 100% response rate.…”

Section: Discussionmentioning

confidence: 99%

“…The treatment schedules were different, but all studies showed a nearly 100% response rate. Seven of these nine studies were combined with a normfractionated radiotherapy, and two used a hyperfractionated accelerated radiation regimen [5,23]. DLT was either skin toxicity (moist dermatitis grade 4), oral cavity mucositis grade 3, and febrile neutropenia grade 3 (8/9 studies mucositis, 4/9 studies neutropenia als DLT).…”

Section: Discussionmentioning

confidence: 99%

Aggressive Simultaneous Radiochemotherapy with Cisplatin and Paclitaxel in Combination with Accelerated Hyperfractionated Radiotherapy in Locally Advanced Head and Neck Tumors

et al. 2003

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A phase I trial of 96-hour padlitaxel infusion plus accelerated radiotherapy of unrespectable head and neck cancer

Cited by 15 publications

References 11 publications

A Phase I/II trial of concurrent docetaxel and radiation after induction chemotherapy in patients with poor prognosis squamous cell carcinoma of the head and neck

A Phase I/II trial of concurrent docetaxel and radiation after induction chemotherapy in patients with poor prognosis squamous cell carcinoma of the head and neck

Definitive radiochemotherapy of advanced head and neck cancer with carboplatin and paclitaxel

Aggressive Simultaneous Radiochemotherapy with Cisplatin and Paclitaxel in Combination with Accelerated Hyperfractionated Radiotherapy in Locally Advanced Head and Neck Tumors

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