Combination chemotherapy of carboplatin and gemcitabine against solid tumors: a phase I trial

Abstract

The maximum tolerated doses suggested by this trial are lower than those in other similar phase I trials, but they are consistent with those reported by most of the trials investigating gemcitabine either in combination with cisplatin or in heavily pretreated patients. Carboplatin 4.5 mg/ml per min on day 1 plus gemcitabine 800 mg/m2 on days 1, 8, and 15 every 28 days may represent a promising schedule for further phase II trials.

Carboplatin and Gemcitabine in the Palliative Treatment of Stage IV Non-Small Cell Lung Cancer: Definitive Results of a Phase II Trial

“…Finally, the relationship between side effects and number of courses of chemotherapy also merits discussion. Hematological toxicity is known to increase when gemcitabine is combined with carboplatin rather than with cisplatin 10 -15 • 26 -31 • It represented the dose-limiting toxicity in our prior phase I trial 15 , and in our experience it showed a significant correlation with the number of courses of chemotherapy. In particular, the frequency of grade 3-4 neutropenia was significantly higher in patients receiving more than 4 courses of chemotherapy.…”

“…However, it is widely accepted that carboplatin should be only preferred to cisplatin when the aim of the treatment is palliation 9 . In the few last years, many phase I trials have investigated different combinations of carboplatin and gemcitabine, and some schedules were proposed for further phase II trials 10 -14 . In a recent phase I trial, we tested a schedule with doses of carboplatin and gemcitabine fairly lower than those used in other similar trials 15 • In the present study, we Acknowledgments: Supported by Istituto Oncologico Romagnolo (IOR). evaluated the activity and safety of this schedule in the palliative treatment of stage IV NSCLC in a phase II trial.…”

Carboplatin-gemcitabine in the treatment of elderly patients with non-small cell lung cancer: An outcome analysis

“…In our previous experiences we identified a novel schedule in which we use lower doses of carboplatin and gemcitabine in respect with those reported in the most part of the schedules of literature, whose activity and safety seemed to be comparable with those of literature [6][7][8]. In the actual experience, we hypothesize a novel role of our lowdoses schedule for the treatment of elderly patients with advanced NSCLC.…”

“…In this subgroup of patients, the carboplatin-containing doublet is an independent prognostic factor that improves overall survival. The schedule, that we showed to be active and effective in adult patients [6][7][8], seems to maintain its efficacy even in elderly patients with NSCLC, without worsening its safety profile. Nevertheless, further trials are probably needed to definitively validate this novel schedule in the treatment of fit elderly patients with advanced NSCLC.…”

“…In our previous reports, we tested the activity and safety of a novel carboplatin-gemcitabine (CG) schedule in adult patients with advanced NSCLC, without any restriction due to age, performance status or disease extension. This schedule used reduced doses of both carboplatin (Area Under the Curve 4.5 mg/ml/minute on day 1 every 21 days) and gemcitabine (800 mg/m 2 on day 1 and 8 every 21 days) [6][7][8], and showed an activity comparable with that reported in literature at standard doses [6][7][8].…”