Phase I/II trial of biweekly paclitaxel and cisplatin in the treatment of metastatic breast cancer.

Gelmon, Karen A.; O’Reilly, Seamus; Tolcher, Anthony W.; Campbell, Craig I.; Bryce, C.; Ragaz, Joseph; Coppin, Chris; Plenderleith, Ian H.; Ayers, D.; McDermott, Barbara; Nakashima, Lynne; Healey, Diane; Onetto, Nicole

doi:10.1200/jco.1996.14.4.1185

Cited by 55 publications

(27 citation statements)

References 12 publications

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“…The overall remission rate was 44%. Gelmon and colleagues (Gelmon et al, 1996) established the maximum tolerated dose of paclitaxel in combination with cisplatin, repeated biweekly, in patients with metastatic breast cancer. The objective of our trial was to evaluate the response rate and the toxic effects of cisplatin/paclitaxel, repeated biweekly, in previously untreated patients with unresectable, recurrent or metastatic carcinoma of the oesophagus.…”

mentioning

confidence: 99%

Chemotherapy with cisplatin and paclitaxel in patients with locally advanced, recurrent or metastatic oesophageal cancer

Petrasch

Welt²,

Reinacher³

et al. 1998

Br J Cancer

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Summary Single-agent therapy with paclitaxel is effective against both squamous cell carcinoma and adenocarcinoma of the oesophagus. However, only limited data are available on the combination of paclitaxel with other cytotoxic drugs in this entity. Patients with unresectable stage l1l, recurrent or metastatic tumours were treated in a multicentre setting with paclitaxel 90 mg m-2 given over 3 h intravenously, followed by cisplatin 50 mg m-2. The courses were repeated every 14 days. Twenty patients with squamous cell carcinoma or adenocarcinoma of the oesophagus were evaluable for response. The overall remission rate was 40% (8/20), including 15% (3/20) clinically complete responses. Clinical benefit response, defined as relief of dysphagia and/or significant gain in weight, was achieved in 70% of the patients. Neutropenia of CTC grade 3 occurred only in 10% of the patients; no grade 4 neutropenia and no severe thrombocytopenia was encountered. CTC grade 4 neurotoxicity was seen in 5% of patients. Cisplatin/paclitaxel administered every 14 days, was effective in patients with poor prognosis oesophageal cancer and toxicity was acceptable.Keywords: paclitaxel; cisplatin; oesophageal cancer Several chemotherapeutic agents have been adequately investigated in patients with oesophageal cancer, predominantly with squamous cell histology. The most active drugs, with a response rate of at least 20%, are bleomycin, cisplatin, 5-fluorouracil, methotrexate, mitomycin-C and vindesine (Ajani, 1994). Currently, the combination of 5-fluorouracil and cisplatin is considered th6 standard treatment for squamous cell carcinoma of the oesophagus, with 50% of the patients responding to the treatment. Paclitaxel has demonstrated significant clinical activity against a variety of tumours. After a 24-h continuous infusion of 250 mg m-2 paclitaxel, Ajani et al (1994) achieved either a complete or partial response in 32% of oesophageal cancer patients.Only limited data are available on the combination of paclitaxel with other cytotoxic drugs in oesophageal cancer. Ajani et al (1995) have reported the preliminary results of a regimen combining paclitaxel with cisplatin and a continuous infusion of 5-fluorouracil. The overall remission rate was 44%. Gelmon and colleagues (Gelmon et al, 1996) established the maximum tolerated dose of paclitaxel in combination with cisplatin, repeated biweekly, in patients with metastatic breast cancer. The objective of our trial was to evaluate the response rate and the toxic effects of cisplatin/paclitaxel, repeated biweekly, in previously untreated patients with unresectable, recurrent or metastatic carcinoma of the oesophagus.

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mentioning

confidence: 99%

Chemotherapy with cisplatin and paclitaxel in patients with locally advanced, recurrent or metastatic oesophageal cancer

Petrasch

Welt²,

Reinacher³

et al. 1998

Br J Cancer

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“…In previously untreated metastatic breast carcinoma, [33][34][35][36][37][38] the response rate to paclitaxel is 30 -60%, and it is 21-32% in patients with extensive prior therapy, 39 -41 including those who are resistant to anthracyclines. Many studies also have demonstrated significant activity of paclitaxel when combined with other agents including doxorubicin, [42][43][44][45][46][47][48][49][50] cisplatin, [51][52][53] carboplatin, 54 -56 and 5-FU. 57,58 Many of the dose-limiting toxic effects of these combinations are due to the sequence of administration and/or the doses used in the various combinations.…”

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confidence: 99%

“…57,58 Many of the dose-limiting toxic effects of these combinations are due to the sequence of administration and/or the doses used in the various combinations. For example, the dose-limiting toxic effects of paclitaxel and doxorubicin are hematologic, cardiac, and mucositis; 42,43,59 those of paclitaxel and cisplatin are hematologic and neurosensory, [51][52][53] and for paclitaxel and 5-FU they are mucositis, diarrhea, neuropathy, and hematologic toxicity. 57,58 Anthracycline-cyclophosphamide-based regimens are the gold standard, frontline therapy for metastatic breast carcinoma; the overall response (OR) rate is 45-75%, and the complete response (CR) rate is 10 -20%.…”

mentioning

confidence: 99%

Phase I study of vinorelbine and paclitaxel by 3‐hour simultaneous infusion with and without granulocyte colony‐stimulating factor support in metastatic breast carcinoma

Ibrahim

Buzdar

Valero

et al. 2001

Cancer

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“…Two of the six patients had granulocytopenia (< 0.75 × 10 9 l -1 ) on day 14 of the first cycle at this dose level. In the study of Gelmon et al (1996a) dose-limiting neutropenia was seen at a paclitaxel dose of 100 mg m -2 . The latter study included 27 patients with metastatic breast cancer, most of whom had received prior adjuvant chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

“…In two phase I studies, a fixed dose of cisplatin of 60 mg m -2 and an escalating dose of paclitaxel by 3-h infusion in a biweekly schedule was tested (Gelmon et al, 1996a;Swenerton et al, 1996). In the study of Swenerton et al (1996) granulocytopenia, which prevented retreatment at the scheduled time, was the dose-limiting toxicity at a paclitaxel dose level of 120 mg m -2 .…”

Section: Discussionmentioning

confidence: 99%

Phase I study of a biweekly schedule of a fixed dose of cisplatin with increasing doses of paclitaxel in patients with advanced oesophageal cancer

et al. 1999

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SummaryWe performed this dose-finding study with a fixed dose of cisplatin and increasing doses of paclitaxel given every 2 weeks to determine the maximum tolerable dose of this schedule. Sixty-four patients with advanced oesophageal cancer were treated with a cisplatin dose of 60 mg m -2 and increasing doses of paclitaxel from 100 mg m -2 up to 200 mg m -2 both administered over 3 h for a maximum of six cycles in patients with stable disease or eight cycles in responding patients. Patients were retreated when the granulocytes were > 0.75 × 10 9 l -1 and the platelets > 75 × 10 9 l -1 . The dose of paclitaxel could be increased to 200 mg m -2 without encountering dose limiting haematological toxicity. At the dose levels 190 mg m -2 and 200 mg m -2 of paclitaxel cumulative sensory neurotoxicity became the doselimiting toxicity. The dose intensity of paclitaxel calculated over six cycles rose from 50 mg m -2 per week to 85 mg m -2 per week. Only three episodes of granulocytopenic fever were encountered out of a total of 362 cycles of treatment. Of the 59 patients evaluable for response, 31 (52%) had a partial or complete response. In a biweekly schedule with a fixed dose of 60 mg m -2 cisplatin it is possible to increase the dose of paclitaxel to 180 mg m -2 . At higher dose levels, neurotoxicity becomes the dose-limiting toxicity. The observed response rate warrants further investigation of this schedule.

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Phase I/II trial of biweekly paclitaxel and cisplatin in the treatment of metastatic breast cancer.

Abstract: Biweekly paclitaxel and cisplatin is an active combination in the treatment of metastatic breast cancer, including for patients with previous exposure to anthracyclines.

Cited by 55 publications

References 12 publications

Chemotherapy with cisplatin and paclitaxel in patients with locally advanced, recurrent or metastatic oesophageal cancer

Chemotherapy with cisplatin and paclitaxel in patients with locally advanced, recurrent or metastatic oesophageal cancer

Phase I study of vinorelbine and paclitaxel by 3‐hour simultaneous infusion with and without granulocyte colony‐stimulating factor support in metastatic breast carcinoma

Phase I study of a biweekly schedule of a fixed dose of cisplatin with increasing doses of paclitaxel in patients with advanced oesophageal cancer

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