Clinical Trial VICCGI1283
A Randomized, Multicenter, Adaptive Phase II/III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel or Paclitaxel) in Patients with Previously Treated Locally Advanced or Metastatic HER2-Positive Gastric Cancer, Including Adenocarcinoma of the Gastroesophageal Junction
- Protocol No. VICCGI1283
- Open Date: 02/14/2013
- Staging: Phase II/III
- Age Group: Adults
- Scope: National
- Objective: Phase II/III - To select a trastuzumab emtansine dose and schedule for Phase III assessment of treatment for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC), defined as locally advanced or unresectable or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (GEJ) on the basis of safety, pharmacokinetics, and efficacy Phase III - To compare the overall survival (OS) of patients treated with trastuzumab emtansine at the dose and schedule selected in the Phase II portion of the study
- Disease Sites: Gastric/Gastroesophageal
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Docetaxel; Docetaxel (Taxotere); Paclitaxel; Trastuzumab emtansine (T-DM1)
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01641939
- Secondary Protocol No: B027952
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• Adult patients, aged >/= 18 years
• ECOG performance status of 0 or 1.
• Life expectancy of at least 12 weeks from the first dose of study treatment
• Measurable and/or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
• Adequate organ function as determined by the following laboratory results, within 28 days prior to randomization
• Patients must have a history of advanced gastric cancer (AGC), defined as unresectable and locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (GEJ), and must have experienced disease progression during or after first-line therapy for their disease.
• HER2-positive tumor (primary tumor or metastatic lesion) as confirmed by central laboratory HER2 testing (immunohistochemistry and/or in-situ hybridization)
• Patients must have received at least one prior chemotherapy regimen for AGC; prior therapy does not need to have included HER2-directed therapy.
• First-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a combination of at least a platinum- and a fluoropyrimidine-based treatment given concurrently; prior therapy does not need to have included a HER2-directed therapy.
• Adjuvant or neoadjuvant therapy for AGC is allowed.
• An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed therapy until the time of randomization
• Prior treatment with trastuzumab emtansine, docetaxel, or paclitaxel either as single agents or as part of a treatment regimen.
• Treatment with any investigational anticancer drug within 21 days of the first study treatment administration
• More than one prior line of therapy for advanced gastric cancer
• History of other malignancy within the previous 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome
• Brain metastases that are untreated or symptomatic or require any radiation, surgery, or steroid therapy to control symptoms from brain metastases within 1 month of randomization
• Peripheral neuropathy Grade >/=2
• Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, serious cardiac arrhythmia)
• Other current, severe, uncontrolled systemic disease (e.g., clinically significant metabolic disease, wound healing disorders, ulcers)
• Clinically significant bleeding within 30 days before enrollment
• For female patients, current pregnancy or lactation
• Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
• Infection with HIV or hepatitis B virus, hepatitis C virus