An Open-label, Single-center, Phase 1/ 2 Study of Chemoradiotherapy and AT-101 in Patients With Locally Advanced Esophageal or Gastroesophageal Junction Cancer
This study has been terminated.
(Drug not being developed for this indication)
Information provided by:
First received: November 19, 2007
Last updated: January 3, 2013
Last verified: January 2013
This is a Phase 1/ 2, open-label, single-center study of preoperative chemoradiotherapy and AT-101 in patients with locally advanced esophageal or gastroesophageal junction cancer.
Locally Advanced Esophageal or GE Junction Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Single-center, Phase 1/ 2 Study of Chemoradiotherapy and AT-101 in Patients With Locally Advanced Esophageal or Gastroesophageal Junction Cancer|
Resource links provided by NLM:
Further study details as provided by Ascenta Therapeutics:
Primary Outcome Measures:
- Phase 1: Safety and tolerability of AT-101 in combination with chemoradiotherapy, and determine a dose for Phase 2. Phase 2: Determine the pathologic complete response (pathCR) rate and to correlate tumor biomarker expression with clinical response. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess the safety and toxicity of chemoradiotherapy and AT-101 in patients with esophageal or gastroesophageal junction cancer. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2007|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Patients will receive AT-101 starting at 10 mg once daily for 5 of 7 days in conjunction with RT (50.4 Gy for 28 fractions) for approximately 5.5 weeks. Concurrently, patients will receive docetaxel (20 mg/m2) IV weekly (Monday) and 5-fluorouracil (300 mg/m2) as a 24 hour continuous infusion for 5 of 7 days (Monday-Friday) of each RT week for approximately 5 weeks. Patients will continue for full 5.5 weeks unless unacceptable toxicity occurs.
Contacts and Locations