Stomach Neoplasms Clinical Trial
Official title:
A Randomized Phase II Study of PEP02, Irinotecan or Docetaxel as a Second Line Therapy in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
The purpose of this study is to assess objective tumor response in the single agent treatment of PEP02, irinotecan, or docetaxel for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
Palliative chemotherapy has been shown to improve survival compared with best supportive
care alone in patients with unresectable or recurrent gastric cancer. There is no standard
second-line chemotherapy for advanced gastric cancer and no randomized-controlled trial data
suggest a benefit of second-line chemotherapy compared with supportive care alone. Response
rates of second-line therapy in phase II trials are similar to those seen for other cancers
that are more commonly retreated. Combination therapy may achieve higher response rates than
single agents, however, the survival outcome are the same. In addition, data suggest that
patients may obtain symptomatic benefits from second-line therapy. In comparison to the
toxicity profile of single agent with combination regimen, patients are more tolerable to
single agent therapy than combination.
Based on the previous clinical experience in second line chemotherapy of advanced gastric
cancer, the single agent of PEP02, irinotecan and docetaxel are selected as the regimens for
this randomized phase II study. The efficacy and toxicity outcome of the three-arm design
will be a valuable reference for future combination therapy or phase III study design.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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