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An Open-label, Single-center, Phase 1/ 2 Study of Chemoradiotherapy and AT-101 in Patients With Locally Advanced Esophageal or Gastroesophageal Junction Cancer

NCT00561197 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2013-01-04

No results posted yet for this study

Summary

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.

Conditions

  • Locally Advanced Esophageal or GE Junction Cancer

Interventions

DRUG

AT-101

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.

Sponsors & Collaborators

  • Ascenta Therapeutics

    lead INDUSTRY

Principal Investigators

  • Lance Leopold, MD · Ascenta Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00561197 on ClinicalTrials.gov