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Title:
J1330 : MM-111-13-02-04: Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel with or without Trastuzumab in Patients with â??Traditionalâ?? and â??Non-Traditionalâ?? HER2 Expressing Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
Protocol Number:
J1330
Phase:
Phase II
Physician:
Ross Donehower
Purpose:
To determine the benefits of using MM-111 in combination with Paclitaxel and/or Trastuzumab or with Paclitaxel alone in 2 groups of HER2 expressing patients with metastatic or locally advanced (unresectable) HER2 distal esophagus, GE Junction or gastric cancer.
Eligibility:
Metastatic or locally advanced cancer of the distal esophagus, GE junction or stomach-confirmed HER2 expression-received one prior systemic standard fluoropyrimidine/platinum-based therapy with or witout trastuzumab for metastatic disease-good physical condition with good blood counts and organ function-patients who have received paclitaxel or taxane treatment are not eligible
Treatment:
Phase II: This is a multicenter randomized clinical trial that is not blinded. We expected up to 6 participants at Hopkins. Patients will randomized to one of 4 arms:Paclitaxel, Trastuzumab plus MM-111; Paclitaxel plus Trastuzumab; Paclitaxel plus MM-111;or Paclitaxel alone. For specific study drug treatment information, please contact Rosalind Walker, RN, at rwalker3@jhmi.edu.
Population:
Adult
Last Update
04/16/2014 04:02 AM
 

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