NCT02389751

Ganetespib in Combination With Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Stage II-III Esophageal Cancer

GUARDIAN-1 Trial: A Phase 1 Study of Ganetespib in Combination With Chemoradiation for Stage II-III Esophageal Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastroesophageal Junction Adenocarcinoma
• Malignant Neoplasm of the Cervical Esophagus
• Malignant Neoplasm of the Thoracic Esophagus
• Stage IIA Esophageal Cancer AJCC v7
• Stage IIB Esophageal Cancer AJCC v7
• Stage IIIA Esophageal Cancer AJCC v7
• Stage IIIB Esophageal Cancer AJCC v7
• Stage IIIC Esophageal Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
DRUG	Ganetespib	Given IV
DRUG	Paclitaxel	Given IV
RADIATION	Radiation Therapy	Undergo radiation therapy

Timeline

• Start date: 2015-04-10
• Primary completion: 2019-07-16
• Completion: 2019-07-16
• First posted: 2015-03-17
• Last updated: 2019-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study