Continuous toxicity monitoring in phase II trials in oncology.

Response to neoadjuvant chemotherapy in locally advanced gastric and gastroesophageal cancer: Phase II clinical trial

Background: Gastric cancer is an important health problem across the world. Chemotherapy in combination with local treatment is standard treatment for locally advanced gastroesophageal cancers. The purpose of this investigation was evaluation of response and tolerability to neoadjuvant EOX regimen in locoregionally advanced gastric cancer. Materials and Methods: patients with locoregionally adv...

Irinotecan in esophageal cancer.

The limited effectiveness of chemotherapy in esophageal cancer used to palliate metastatic disease or to combine with radiotherapy in locally advanced disease has prompted the evaluation of new systemic agents. Irinotecan (CPT-11, Camptosar) has shown promising activity in a number of gastrointestinal cancers, including esophageal cancer. The phase II evaluation of the combination of weekly iri...

Phase I and pharmacokinetic evaluations of UFT plus oral leucovorin.

The phase I development program of tegafur and uracil (UFT) in the United States has included evaluation of the drug as a single agent and subsequent studies of its biochemical modulation by oral leucovorin. Phase I trials of single-agent UFT examined both a 5-day schedule repeated every 21 days and a 28-day schedule repeated every 35 days. In all of the trials the total dose was divided by thr...

Phase II study of continuous-infusion high-dose ifosfamide in advanced and/or metastatic pretreated soft tissue sarcomas.

BACKGROUND Ifosfamide has important activity in pretreated soft tissue sarcomas (STS), and recent data support a clinically significant dose-response relationship for this agent. Administration by continuous infusion and hematopoietic support have rendered dose intensification regimens possible by reducing both hematologic and non-hematologic toxicities. The optimal dose and schedule of ifosfam...

Continuous Safety Monitoring of Excess Toxicity in Single Arm Early Phase Biomarker Driven Trials