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

January 3, 2013 updated by: Ascenta Therapeutics

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.

Study Overview

Status

Terminated

Conditions

Locally Advanced Esophageal or GE Junction Cancer

Intervention / Treatment

Drug: AT-101

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Texas
  - Houston, Texas, United States
    - MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male or female patients age ≥18 years
Histologically confirmed primary (non-recurrent) adenocarcinoma (AC) or squamous cell carcinoma of the esophagus or AC of the gastroesophageal (GE) junction.
For Phase 1: Phase 1 patients must have unresectable disease (Stage II to IVa). A patient can be unresectable for medical reasons or technical reasons but eligible for chemoradiation.
For Phase 2: Phase 2 patients must have resectable cancer defined as: T2, T3, N0; OR T1-3, N+
Patients must have archived tumor tissue to correlate tumor biomarker expression with clinical response. Availability of tumor specimens in paraffin blocks or at least two unstained slides must be confirmed prior to study entry. Results will not be used to determine patient eligibility for the study.
ECOG performance status 0-1
Adequate hematologic function
Adequate liver and renal function
Ability to swallow and retain oral medication.

Exclusion Criteria:

Patients with distant metastasis, including M1b lymph node status. (M1b status allowed on Phase I only for patients appropriate for chemoradation). Lymph nodes suspicious of M1b status by diagnostic imaging must be verified by fine-needle aspiration cytology. (Phase 2 only)
For Phase 2: Patients with positive pleural, pericardial, or peritoneal cytology.
For Phase 2: Patients with carcinoma of the cervical esophagus.
For Phase 2: Patients with clinical evidence of metastasis to cervical or supraclavicular lymph nodes.
Prior chemotherapy or radiotherapy for esophageal or gastroesophageal junction cancer. Phase 1 patients with prior chemotherapy are permitted to enter.
Prior radiotherapy that would overlap the anticipated study treatment fields or radiotherapy to >30% of the marrow cavity (no prior chest irradiation).
Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel are excluded. Subjects with ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are also excluded.
Pregnant or nursing females. Fertile patients (male and female) must use effective contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the safety and toxicity of chemoradiotherapy and AT-101 in patients with esophageal or gastroesophageal junction cancer. Time Frame: 1 year	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascenta Therapeutics

Investigators

Study Director: Lance Leopold, MD, Ascenta Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 19, 2007

First Submitted That Met QC Criteria