Phase I and pharmacologic study of docetaxel and cisplatin in patients with advanced solid tumors.

Pronk, Linda; Schellens, Jan H.M.; Planting, A. S. T.; Bent, Martin J. van den; Hilkens, P. H. E.; Burg, M.E.L. van der; Boer-Dennert, M. de; Ma, Jun; Blanc, C.; Harteveld, M.; Bruno, René; Stoter, G.; Verweij, Jaap

doi:10.1200/jco.1997.15.3.1071

Cited by 60 publications

(29 citation statements)

References 18 publications

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“…The present study evaluated docetaxel in combination with cisplatin which is generally considered to be the most active agent against urothelial cancer. Prior phase I studies showed the feasibility of this combination and its activity on different tumours (Pronk et al, 1997). The response rate observed for urothelial cancer in our study is within the range of the responses seen with other conventional (Sternberg et al, 1989) and newer schedules (Von der Maase et al, 1999;Dreicer et al, 2000) which are considered highly active.…”

Section: Discussionsupporting

confidence: 78%

Phase II multicentre study of docetaxel plus cisplatin in patients with advanced urothelial cancer

Muro

Marcuello

Gumà³

et al. 2002

Br J Cancer

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A multicentre phase II trial was undertaken to evaluate the activity and toxicity of docetaxel plus cisplatin as first-line chemotherapy in patients with urothelial cancer. Thirty-eight patients with locally advanced or metastatic transitional-cell carcinoma of the bladder, renal pelvis or ureter received the combination of docetaxel 75 mg m 72 and cisplatin 75 mg m 72 on day 1 and repeated every 21 days, to a maximum of six cycles. The median delivered dose-intensity was 98% (range 79 -102%) of the planned dose for both drugs. There were seven complete responses and 15 partial responses, for and overall response rate of 58% (95% CI, 41 -74%). Responses were even seen in three patients with hepatic metastases. The median time to progression was 6.9 months, and the median overall survival was 10.4 months. Two patients who achieved CR status remain free of disease at 4 and 3 years respectively. Grade 3 -4 granulocytopenia occurred in 27 patients, resulting in five episodes of febrile neutropenia. There was one toxic death in a patient with grade 4 granulocytopenia who developed acute abdomen. Grade 3 -4 thrombocytopenia was rare (one patient). Other grade 3 -4 toxicities observed were anaemia (three patients), vomiting (five patients), diarrhoea (four patients), peripheral neuropathy (two patients) and non-neutropenic infections (seven patients). Docetaxel plus cisplatin is an effective and well-tolerated regimen for the treatment of advanced urothelial cancer, and warrants further investigation.

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Section: Discussionsupporting

confidence: 78%

Phase II multicentre study of docetaxel plus cisplatin in patients with advanced urothelial cancer

Muro

Marcuello

Gumà³

et al. 2002

Br J Cancer

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“…The incidence of sensory neuropathy of the combination was slightly higher than the incidence reported for docetaxel as a single agent (49%) (Hilkens et al, 1996). In a phase I study combining paclitaxel and cisplatin and in a phase I study on the docetaxel-cisplatin combination (Hilkens et al, 1997;Pronk et al, 1997), the incidence of sensory neuropathy of the combination was higher than that reported for docetaxel as a single agent (Hilkens et al, 1996). It was suggested that these agents act synergistically in producing neurotoxicity.…”

Section: Discussionmentioning

confidence: 86%

Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours

Pronk

Schrijvers²,

Schellens³

et al. 1998

Br J Cancer

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Summary Docetaxel and ifosfamide have shown significant activity against a variety of solid tumours. This prompted a phase I trial on the combination of these drugs. This phase I study was performed to assess the feasibility of the combination, to determine the maximum tolerated dose (MTD) and the side effects, and to propose a safe schedule for further phase 11 studies. A total of 34 patients with a histologically confirmed solid tumour, who were not pretreated with taxanes or ifosfamide and who had received no more than one line of chemotherapy for advanced disease were entered into the study. Treatment consisted of docetaxel given as a 1-h infusion followed by ifosfamide as a 24-h infusion (schedule A), or ifosfamide followed by docetaxel (schedule B) every 3 weeks. Docetaxel doses ranged from 60 to 85 mg m-2 and ifosfamide doses from 2.5 to 5.0 g m-2. Granulocytopenia grade 3 and 4 were common (89%), short lasting and ifosfamide dose dependent. Febrile neutropenia and sepsis occurred in 17% and 2% of courses respectively. Non-haematological toxicities were mild to moderate and included alopecia, nausea, vomiting, mucositis, diarrhoea, sensory neuropathy, skin and nail toxicity and oedema. There did not appear to be any pharmacokinetic interaction between docetaxel and ifosfamide. One complete response (CR) (soft tissue sarcoma) and two partial responses (PRs) were documented. A dose of 75 mg m-2 of docetaxel combined with 5.0 g m-2 ifosfamide appeared to be manageable. Schedule A was advocated for further treatment.

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“…Subsequent studies, however, consistently raised concerns about toxicity, notably neutropenia. 1,20,21 Preclinical studies have demonstrated that docetaxel modulates the intracellular metabolism of other drugs (5-FU and cisplatin), which explains the mechanism underlying the synergistic effect.…”

Section: Discussionmentioning

confidence: 99%

A randomized phase 2 study of docetaxel and S‐1 versus docetaxel and cisplatin in advanced gastric cancer with an evaluation of SPARC expression for personalized therapy

Jeung

Rha

et al. 2010

Cancer

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BACKGROUND:The purpose of this study was to compare 2 weekly docetaxel-based regimens as first-line treatments for advanced gastric cancer and to investigate the expression of secreted protein acidic and rich in cysteine (SPARC) and its abilities to predict treatment-related clinical outcomes. METHODS: Patients were randomly selected to receive 3 weekly cycles of docetaxel (35 mg/m 2 on days 1 and 8) plus S-1 (35 mg/m 2 each twice daily on days 1-14)

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Phase I and pharmacologic study of docetaxel and cisplatin in patients with advanced solid tumors.

Cited by 60 publications

References 18 publications

Phase II multicentre study of docetaxel plus cisplatin in patients with advanced urothelial cancer

Phase II multicentre study of docetaxel plus cisplatin in patients with advanced urothelial cancer

Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours

A randomized phase 2 study of docetaxel and S‐1 versus docetaxel and cisplatin in advanced gastric cancer with an evaluation of SPARC expression for personalized therapy

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