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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2010 by Ascenta Therapeutics. Recruitment status was Active, not recruiting

First Received on November 19, 2007. Last Updated on February 3, 2010 History of Changes

Sponsor:	Ascenta Therapeutics
Information provided by:	Ascenta Therapeutics
ClinicalTrials.gov Identifier:	NCT00561197

Purpose

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.

Condition	Intervention	Phase
Locally Advanced Esophageal or GE Junction Cancer	Drug: AT-101	Phase I Phase II

Study Type:	Interventional
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:

MedlinePlus related topics: Cancer Esophagus Disorders

U.S. FDA Resources

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 ]

Estimated Enrollment:	48
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561197

Locations

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

Sponsors and Collaborators

Ascenta Therapeutics

Investigators

Study Director:

Lance Leopold, MD

Ascenta Therapeutics, Inc.

More Information

No publications provided

Responsible Party:	Kimberli Brill, Associate Director, Clinical Development, Ascenta Therapeutics
ClinicalTrials.gov Identifier:	NCT00561197 History of Changes
Other Study ID Numbers:	AT-101-CS-102
Study First Received:	November 19, 2007
Last Updated:	February 3, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gossypol
Gossypol acetic acid
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Contraceptive Agents, Female
Spermatocidal Agents
Antispermatogenic Agents

ClinicalTrials.gov processed this record on February 12, 2012