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Clinical Trial VICCGI1306

Title

Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel with Trastuzumab in Patients with HER2 Positive Carinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy

Principal Investigator(s)

Jordan Berlin

Details

  • Protocol No. VICCGI1306
  • Open Date: 07/11/2013
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: To compare the patient Progression Free Survival (PFS) between the experimental and comparator arm of the study in the following defined patient populations: Overall study population and HRG high poplulation comprised of patients with HRG levels at or above the median in archived tumor tissue samples assessed centrallly by RT-PCR.
  • Disease Sites: Gastrointestinal; Esophageal; Gastric/Gastroesophageal
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Herceptin; MM-111; Paclitaxel; Trastuzumab (Herceptin)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01774851
  • Secondary Protocol No: MM-111-13-02-04

Description

Participants are being asked to take part in this research study because they have metastatic or locally advanced cancer (cancer that has spread from its original location) of the esophagus, gastroesophageal (GE) junction or stomach and the disease worsened since the last treatment. The study is also specific to patients with a certain type of cancer cells known as Human Epidermal Growth Factor Receptor 2 (HER2 or ErbB2), which are cells that can lead to increased cancer growth. The current study is evaluating MM-111, an investigational product that is not approved by the U.S. Food and Drug Administration (FDA) or in any country outside of the United States, in patients that have cancer like yours, in combination with paclitaxel (a drug used to treat your type of cancer) and trastuzumab (a drug used to treat HER2 cancer cells).MM-111 is an antibody that binds to specific proteins found on the surface of cells. These proteins, ErbB2 and ErbB3 (also known as HER2 and HER3), are involved with cell growth. In laboratory studies, MM-111 has been shown to bind to ErbB2 and ErbB3 and interfere with tumor cell growth. The main purpose of this study is to compare the time from when a patient begins this study to when their disease progresses (known as Progression Free Survival or PFS), between each of 4 possible combinations of the study drugs. Researchers are also trying to learn about patient survival, safety, and how well MM-111 does or does not work against cancer.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

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