Paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a phase II trial.

Johnson, David H.; Paul, D. M.; Hande, Kenneth R.; Shyr, Yu; Blanke, Charles D.; Murphy, Brian R.; Lewis, Margaret; Vore, R. F. De

doi:10.1200/jco.1996.14.7.2054

Cited by 119 publications

(30 citation statements)

References 19 publications

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“…As a consequence, carboplatin was selected (Bunn et al, 1994;Langer et al, 1995;Muggia et al, 1995;Belani et al, 1996;Johnson et al, 1996;Choy et al, 2000;Schiller et al, 2002).…”

Section: Discussionmentioning

confidence: 99%

“…In a recent survey, a carboplatin-containing combination was found to be the most widely favoured option for first-line chemotherapy in all stages of NSCLC among US medical oncologists (Choy et al, 2000). This relates to ease of administration on an out-patient basis, manageable toxicity profiles compared with other platinumcontaining regimens and promising phase II trial results (Langer et al, 1995;Muggia et al, 1995;Belani et al, 1996;Johnson et al, 1996).…”

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confidence: 99%

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A phase I and pharmacokinetic study of indisulam in combination with carboplatin

et al. 2007

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Indisulam (E7070) is an anticancer agent that is currently being evaluated in phase II clinical studies. A significant reduction in glutathione synthetase and glutathione reductase transcripts by indisulam provided a molecular basis for its combination with platinum agents. Indisulam demonstrated high anti-tumour activity in various preclinical cancer models. The objectives of this study were (1) to determine the recommended dose of indisulam in combination with carboplatin in patients with solid tumours and (2) to evaluate the pharmacokinetics of the combination. Patients with solid tumours were treated with indisulam in combination with carboplatin. Indisulam (350, 500, or 600 mg m À2 ) was given as a 1-hour intravenous infusion on day 1 and carboplatin (5 or 6 mg min ml À1 ) as an intravenous infusion over 30 min on day 2 of a three-weekly cycle. Sixteen patients received study treatment and were eligible. Thrombocytopenia was the major dose limiting toxicity followed by neutropenia. Both drugs contributed to the myelosuppressive effect of the combination. Indisulam 500 mg m À2 in combination with carboplatin 6 mg min ml À1 was identified not to cause dose limiting toxicity, but a delay of re-treatment by 1 week was required regularly to allow recovery from myelosuppression. The recommended dose and schedule for an envisaged phase II study in patients with non-small cell lung cancer is indisulam 500 mg m À2 in combination with carboplatin 6 mg min ml À1 repeated four-weekly. Patients who do not experience severe thrombocytopenia at cycle 1 will be permitted to receive an escalated dose of indisulam of 600 mg m À2 from cycle 2 onwards.

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“…As a consequence, carboplatin was selected (Bunn et al, 1994;Langer et al, 1995;Muggia et al, 1995;Belani et al, 1996;Johnson et al, 1996;Choy et al, 2000;Schiller et al, 2002).…”

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

A phase I and pharmacokinetic study of indisulam in combination with carboplatin

et al. 2007

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“…Pirker et al (1995) (1998) 78(2), [251][252][253][254][255][256] carboplatin in 53 patients with advanced NSCLC. In contrast, Johnson et al (1996) used the same paclitaxel and carboplatin combination and obtained a relatively disappointing response rate of 27%, a median survival time of 38 weeks, and a 1-year survival of 32% in patients with stage IV NSCLC. Prospective randomized trials that compare these new combination regimens with an existing cisplatin-containing regimen are necessary to determine whether or not these new agents will truly improve therapeutic options for patients with advanced NSCLC.…”

Section: Discussionmentioning

confidence: 99%

A phase II trial of combination of CPT-11 and cisplatin for advanced non-small-cell lung cancer

Masuda

Fukuoka²,

Fujita³

et al. 1998

Br J Cancer

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Summary A phase trial of the combination of irinotecan (CPT-11) with cisplatin in advanced non-small cell lung cancer (NSCLC) showed a very promising response rate of 54% in previously untreated NSCLC patients. This study was conducted to confirm the activity and toxicities of CPT-11 and cisplatin combination for previously untreated NSCLC in a multi-institutional phase 11 study. Seventy patients with stage IIIB or IV NSCLC received CPT-11 60 mg m-2 intravenously (IV) on days 1, 8 and 15, and cisplatin 80 mg m-2 (IV) on day 1 every 4 weeks. Assessments were made of response, survival and toxicities. Sixty-nine were eligible, and evaluable for toxicities and survival, and 64 patients evaluable for response. Thirty-three patients (52%; 95% confidence interval 39-64%) achieved an objective response, with one complete response (2%) and 32 partial responses (50%). The median duration of response was 19 weeks and the overall median survival time was 44 weeks. The 1-year survival rate was 33%. The major toxic effects were leucopenia and diarrhoea. Grade 3 or 4 leucopenia, neutropenia, and diarrhoea occurred in 32 patients (46%), 53 patients (80%), and 13 patients (19%) respectively. A combination of CPT-11 and cisplatin is very effective against non-small-cell lung cancer with acceptable toxicities.

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“…Carboplatin has demonstrated activity in a number of solid tumors, including ovarian and lung cancer and is now widely utilized. 4,5 Carboplatin does not produce the nephrotoxicity of cisplatin, and is associated with less neurotoxicity than cisplatin. Its major toxicity is myelosuppression, unlike cisplatin.…”

Section: Introductionmentioning

confidence: 99%

Phase II study of carboplatin in blast crisis of chronic myeloid leukemia: Eastern Cooperative Oncology Group Study E1992

et al. 1998

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This study was a phase II evaluation of the activity of carboplatin in patients with Philadelphia chromosome positive accelerated or blastic phase of CML. Carboplatin, 250 mg/m 2 /day as an intravenous continuous infusion was given for 5 days, for a total dose of 1250 mg/m 2 per course. If necessary, a second induction course could be given, and patients achieving complete remission were to receive an additional consolidation cycle at the same dose. Thirty-six patients were eligible and evaluable. There were five complete and three partial remissions for an overall response rate of 22% (95% CI 10.1-39.1%). The complete remission rate was 13.9% (95% CI 4.7-29.9%). The median remission duration was 3 months (range 1.4-8.94 months) and the median survival on study for all patients was 3.5 months (95% CI, 2.4-11.4 months). The median survival of responders was 12.8 months (95% CI, 3.6-17.2 months). Three eligible patients survived 2.0, 2.5 and 3.5 years following carboplatin therapy. Carboplatin has activity in blast crisis of CML, but responses are brief. Response did allow one patient to proceed to bone marrow transplantation and two other patients to continue therapy for chronic phase disease before returning to blast crisis. Activity in combination regimens should be explored.

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Paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a phase II trial.

Abstract: Paclitaxel plus carboplatin is a moderately active regimen in patients with advanced NSCLC and warrants comparison with existing cisplatin-based regimens in a prospective randomized trial. The toxicities of this regimen are well tolerated in patients with a good PS.

Cited by 119 publications

References 19 publications

A phase I and pharmacokinetic study of indisulam in combination with carboplatin

A phase I and pharmacokinetic study of indisulam in combination with carboplatin

A phase II trial of combination of CPT-11 and cisplatin for advanced non-small-cell lung cancer

Phase II study of carboplatin in blast crisis of chronic myeloid leukemia: Eastern Cooperative Oncology Group Study E1992

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