Ganetespib in Combination With Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Stage II-III Esophageal Cancer
|ClinicalTrials.gov Identifier: NCT02389751|
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Carboplatin Drug: Ganetespib Drug: Paclitaxel Radiation: Radiation Therapy||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||GUARDIAN-1 Trial: A Phase 1 Study of Ganetespib in Combination With Chemoradiation for Stage II-III Esophageal Carcinoma|
|Actual Study Start Date :||April 10, 2015|
|Actual Primary Completion Date :||July 16, 2019|
|Actual Study Completion Date :||July 16, 2019|
Experimental: Treatment (ganetespib, paclitaxel, carboplatin, radiation)
Patients receive ganetespib 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
Radiation: Radiation Therapy
Undergo radiation therapy
- MTD and recommended phase II dose of ganetespib, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: 70 days ]The MTD is defined as the dose for which the posterior mean probability of dose-limiting toxicity is closest to 30%.
- Response rate based on FDG-PET/CT +/- CT imaging response assessment after completion of chemoradiation [ Time Frame: At 6 weeks after completion of chemoradiation therapy ]
- OS [ Time Frame: Up to 5 years ]
- PFS [ Time Frame: Up to 5 years ]
- pCR for patients who undergo surgical resection after neoadjuvant therapy [ Time Frame: Up to 10 weeks after completion of chemoradiation therapy ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389751
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Steven Lin||M.D. Anderson Cancer Center|