Gastroesophageal Junction Adenocarcinoma Clinical Trial
Official title:
GUARDIAN-1 Trial: A Phase 1 Study of Ganetespib in Combination With Chemoradiation for Stage II-III Esophageal Carcinoma
This phase I trial studies the side effects and best dose of ganetespib when given together with paclitaxel, carboplatin, and radiation therapy in treating patients with stage II-III esophageal cancer. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving ganetespib in combination with paclitaxel, carboplatin, and radiation therapy may be a better treatment for patients with esophageal cancer.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated disease (MTD) and the recommended phase II dose of
ganetespib to combine with standard carboplatin and paclitaxel chemotherapy and radiotherapy
in stage II-III patients with esophageal carcinoma.
SECONDARY OBJECTIVES:
I. To assess the response rate based on fludeoxyglucose-positron emission tomography/computed
tomography (FDG-PET/CT) +/- CT with contrast imaging response assessment after completion of
chemoradiation.
II. To determine the 1 year overall survival (OS) rate. III. To determine the
progression-free survival (PFS) rate. IV. To determine the pathologic complete response (pCR)
rate for patients who undergo surgery.
OUTLINE: This is a dose-escalation study of ganetespib.
Patients receive ganetespib intravenously (IV) over 1 hour, paclitaxel IV over 1 hour, and
carboplatin IV over 30 minutes once a week on day 1. Patients also undergo radiation therapy
5 days a week for 5.5 weeks or for a total of 28 treatments. Treatment continues for 28
treatment days (5.5 weeks) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year,
every 4 months for 1 year, and then every 6 months for 3 years.
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