Clinical Trials

Esophageal or Gastroesophageal Junction Cancer

Trial Number—AT-101-CS-102

An open-label, single center phase I/II trial to evaluate the safety and efficacy of the combination of chemoradiotherapy and AT-101 in patients with locally advanced esophageal or gastroesophageal junction cancer

Primary Objective

• To evaluate the safety and tolerability of AT-101 in combination with chemoradiotherapy and to determine the dose for phase II
• In the phase II portion of the study, to determine the pathologic complete response rate and to correlate tumor biomarker expression with clinical response

Secondary Objective

• To assess the safety and toxicity of chemoradiotherapy and AT-101 in patients with esophageal or gastroesophageal junction cancer

Key Inclusion Criteria

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

Key Exclusion Criteria

1. Patients with distant metastases, including M1b lymph node status. (M1b status allowed on phase I only for patients appropriate for chemoradiation.) Lymph nodes suspicious of M1b status by diagnostic imaging must be verified by fine-needle aspiration cytology. (phase II only)
2. For phase II: patients with positive pleural, pericardial, or peritoneal cytology
3. For phase II: patients with carcinoma of the cervical esophagus
4. For phase II: patients with clinical evidence of metastasis to cervical or supraclavicular lymph nodes
5. Prior chemotherapy or radiotherapy for esophageal or gastroesophageal junction cancer. Phase I patients with prior chemotherapy are permitted to enter.
6. Prior radiotherapy that would overlap the anticipated study treatment fields or radiotherapy to >30% of the marrow cavity (no prior chest irradiation).
7. 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.
8. Pregnant or nursing females. Fertile patients (male and female) must use effective contraception.

Location and Contact Information

For more information on this trial, please contact Ms. Brookes or Dr. Leopold using the information provided below.

    Melissa Brookes               (610) 408-0301     mbrookes@ascenta.com
    Lance Leopold, MD         (610) 408-0301     lleopold@ascenta.com

This study is currently being conducted at MD Anderson Cancer Center.

Trial Identification Number

NCT00561197

For more information on this trial, please visit www.clinicaltrials.gov