Esophageal Cancer Clinical Trial
A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
Summary
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone
Full Description
This is a randomized, open Label, Phase 2 Study of MM-111 and Paclitaxel withTrastuzumab in Patients with HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy. Approximately 120 patients will be randomized in a 1:1 ratio between the experimental and comparator arms.
Eligibility Criteria
Inclusion Criteria:
Patients must have documentation of histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the distal esophagus, GE junction or stomach
Patients must have documentation of histologically or cytologically confirmed HER2 expression
Patients must be ≥18 years of age
Patients must have ECOG PS of 0, 1, or 2
Patients must have adequate hematologic status, renal and hepatic function
Exclusion Criteria:
Patients with known hypersensitivity to any of the components of MM-111
Patients with a known history of hypersensitivity to paclitaxel or other drugs formulated in Cremophor® EL
Patients with a known history of hypersensitivity to trastuzumab or any of its components (group 1 patients only)
Patients with an active infection or with an unexplained fever >38.5°C
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There are 21 Locations for this study
Birmingham Alabama, 35294, United States
Los Angeles California, 90089, United States
Los Angeles California, 90095, United States
Stanford California, 94305, United States
Denver Colorado, 80218, United States
Ocala Florida, 34471, United States
Saint Petersburg Florida, 33705, United States
Urbana Illinois, 61801, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02114, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89135, United States
Buffalo New York, 14263, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Wenatchee Washington, 98801, United States
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