A late phase II study of RP56976 (docetaxel) in patients with advanced or recurrent breast cancer

Adachi, Isamu; Watanabe, Tôru; Takashima, S; Narabayashi, Masaru; Horikoshi, N; Aoyama, Hideaki; Taguchi, Tetsuo

doi:10.1038/bjc.1996.37

Cited by 75 publications

(35 citation statements)

References 8 publications

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“…The significantly lower dosage of the drug used here is the most likely explanation for this inconsistency. A higher dose may be clinically more effective, since the anti-tumour activity of docetaxel probably depends on the dose (Fumoleau et al, 1993;Adachi et al, 1996;Dieras et al, 1996). However, higher doses of docetaxel could not be used given the results of phase I trails in Japan (Taguchi et al, 1994).…”

Section: Discussionmentioning

confidence: 99%

“…Clinical trials to date have demonstrated that docetaxel has significant and consistent anti-tumour activities in a variety of solid tumours, including breast cancer, non-small-cell lung cancer and ovarian cancer (Cerny et al, 1994;Francis et al, 1994;Adachi et al, 1996;Dieras et al, 1996;Kunitoh et al, 1996). With regard to PC, preclinical studies have shown docetaxel to be active in PC models (Bissery et al, 1991), and two clinical trials of docetaxel at 100 mg m Ϫ2 have demonstrated a promising anti-tumour activity in PC (Rougie et al, 1994;Abbruzzese et al, 1995).…”

Section: Discussionmentioning

confidence: 99%

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Phase II study of docetaxel in patients with metastatic pancreatic cancer: a Japanese cooperative study

et al. 1999

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Pancreatic ductal cancer (PC) is difficult to treat, with most patients surgically unresectable at the time of diagnosis. Moreover, even for those who are resected, the risk of recurrence is exceedingly high, and the outcome remains unsatisfactory. The prognosis of unresectable PC patients is also extremely poor, mainly because currently available chemotherapeutic agents are largely ineffective. Accordingly, there is a clear need for new, effective agents in the management of PC. New agents with unique mechanisms of action are attractive candidates for clinical trials with the hope that their anti-tumour activity will be translated into long-term survival.Docetaxel, which is a member of the family of taxanes, is one of the most important new chemotherapeutic agents to be found in recent years (Bissett et al, 1993;Cortes and Pazdur, 1995;Eisenhauer, 1995). It acts by enhancing microtubule assembly and inhibiting tubulin depolymerization, thus disrupting cell division (Schiff et al, 1979;Guéritte-Voegelein et al, 1991;Rowinsky and Donehower, 1995). This mechanism of action is unlike any of the standard cytotoxic agents, and therefore docetaxel has the potential for activity against human solid tumours, including PC, that are refractory to established anti-cancer agents. In fact, two phase II trials of advanced PC, which were conducted in France and the USA, have reported high response rates (20%) and relatively longer survival with the drug administered at 100 mg m Ϫ2 over a 1-h period (Rougie et al, 1994;Abbruzzese et al, 1995).We report here our results of a cooperative phase II study of moderate-dose (60 mg m -2 ) docetaxel in Japanese patients with previously untreated metastatic PC. In our country, the recommended dose for phase II trials of docetaxel is 60 mg m Ϫ2 infused over a 1-h session, because a Japanese phase I trial determined the maximum-tolerated dose (MTD) to be 70-90 mg m Ϫ2 , with leucocytopenia as the dose-limiting toxicity (Taguchi et al., 1994). PATIENTS AND METHODS PatientsPatients eligible for study entry had metastatic PC for which they had not received any treatment. Each patient was required to meet the following eligibility criteria: a performance status (PS) of 0-2; 15-74 years of age; at least one bidimensionally measurable tumour; estimated life expectancy ≥ 2 months after study entry; adequate renal function (normal serum creatinine and blood urea nitrogen levels); adequate liver function (total bilirubin level ≤ 1.5 mg dl Ϫ1 (or ≤ 3.0 mg dl Ϫ1 after biliary drainage if the patient had obstructive jaundice); adequate serum transaminases (GOT, GPT) levels ≤ 2 times upper normal limit (UNL) (or ≤ 3 times Phase II study of docetaxel in patients with metastatic pancreatic cancer: a Japanese cooperative study Summary Docetaxel has been reported to show promising anti-tumour activity in pancreatic ductal cancer (PC). This study was conducted to evaluate the activity and toxicity of moderate-dose (60 mg m Ϫ2 ) docetaxel in Japanese chemo-naive patients with measurable metastatic PC. The pa...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Phase II study of docetaxel in patients with metastatic pancreatic cancer: a Japanese cooperative study

et al. 1999

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“…These results suggested that d-allose treatment enhanced the anticancer effects of docetaxel and may reduce the side effects of the chemotherapeutic drug by reducing the total dose of docetaxel required. Major toxicities of docetaxel are neutropenia, mucositis, peripheral neuropathy and pulmonary disorders (37). Concurrent radiation therapy may increase docetaxel toxicity.…”

Section: Discussionmentioning

confidence: 99%

Effects of d-allose in combination with docetaxel in human head and neck cancer cells

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Hoshikawa

Kamitori

et al. 2014

International Journal of Oncology

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Abstract. In this study we investigated the combined effects of docetaxel and d-allose in HSC3 human oral carcinoma cells. The dose enhancement ratios at the 25% survival level were 1.3 and 1.71 for combined treatment with 10 or 25 mM d-allose, respectively. Apoptosis was significantly increased by addition of d-allose. Additionally, a synchronous increase in the G 2 /M-phase population was observed after docetaxel plus d-allose treatment. In vivo experiments revealed that docetaxel plus d-allose was more effective than either agent alone. Thus, d-allose enhanced the anticancer effects of docetaxel, and combined treatment may be useful to achieve clinical efficacy with reduced toxicity.

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“…A secondary objective was to determine the pharmacokinetic profile of docetaxel in the combination. The starting docetaxel dose of 60 mg m 72 was selected on the basis of its known antitumour activity and good safety profile when administered as a single agent (Adachi et al, 1996). The dose of cyclophosphamide was fixed at 600 mg m 72 since this is the effective dose considered active while producing little toxicity in current protocols.…”

Section: Docetaxelmentioning

confidence: 99%

“…The reduced incidence and severity of docetaxel-related fluid retention in this and other recent studies is probably due to the routine administration of a 3-day corticosteroid premedication regimen (Riva et al, 1997). Docetaxel 60 mg m 72 was chosen as the starting dose in this study on the basis of its antitumour activity and tolerability as a single agent (Adachi et al, 1996). It was therefore not surprising that antitumour activity was observed at each docetaxel and cyclophosphamide dose level, and at all disease sites.…”

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Phase I study of docetaxel in combination with cyclophosphamide as first-line chemotherapy for metastatic breast cancer

et al. 2002

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This phase I was study conducted to establish the maximum tolerated dose, dose-limiting toxicity, and recommended dose of docetaxel in combination with cyclophosphamide as first-line chemotherapy for metastatic breast cancer. Twenty-six patients were treated with cyclophosphamide (600 mg m 72 , intravenous bolus) followed by docetaxel (60, 75 or 85 mg m 72, 1-h intravenous infusion) every 3 weeks. The maximum tolerated dose was docetaxel 85 mg m 72 with cyclophosphamide 600 mg m 72 , the dose-limiting toxicity being febrile neutropenia. Grade 4 neutropenia was experienced by all patients, but was generally brief. Otherwise, the combination was well tolerated with few acute and no chronic non-haematological toxicities of grade 3/4. Activity was observed at all dose levels and disease sites, and the overall response rate was 42% (95% confidence interval 22 -61%). The pharmacokinetics of docetaxel were not modified by cyclophosphamide coadministration. These findings establish a recommended dose of docetaxel 75 mg m 72 in combination with cyclophosphamide 600 mg m 72 every three weeks for phase II evaluation.

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A late phase II study of RP56976 (docetaxel) in patients with advanced or recurrent breast cancer

Cited by 75 publications

References 8 publications

Phase II study of docetaxel in patients with metastatic pancreatic cancer: a Japanese cooperative study

Phase II study of docetaxel in patients with metastatic pancreatic cancer: a Japanese cooperative study

Effects of d-allose in combination with docetaxel in human head and neck cancer cells

Phase I study of docetaxel in combination with cyclophosphamide as first-line chemotherapy for metastatic breast cancer

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