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Sponsors and Collaborators: |
American College of Surgeons National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00757172 |
RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with panitumumab and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving panitumumab together with docetaxel, cisplatin, radiation therapy, and surgery works in treating patients with newly diagnosed, locally advanced esophageal cancer or cancer of the gastroesophageal junction.
Condition | Intervention | Phase |
---|---|---|
Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer |
Biological: panitumumab Drug: cisplatin Drug: docetaxel Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Neoadjuvant Therapy With Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of the Distal Esophagus |
Estimated Enrollment: | 69 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive panitumumab IV over 1 hour, docetaxel IV over 1 hour, and cisplatin IV over 1-2 hours on day 1 in weeks 1, 3, 5, 7, and 9. Patients also undergo radiotherapy once daily 5 days a week beginning in week 5 and continuing for 5.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 6-9 weeks after completion of chemoradiotherapy, patients with no evidence of metastatic disease undergo esophagectomy.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for
1 year OR every 6 months for 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biopsy-proven adenocarcinoma of the distal esophagus or gastroesophageal junction, meeting all of the following criteria:
Clinical stage T1-3,N1,M0; T3,N0,M0; or T1-3,N0-1,M1a (celiac adenopathy must be ≤ 2 cm by esophageal ultrasound) disease
Locally advanced disease
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, California | |
University of California Davis Cancer Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
United States, Illinois | |
Cancer Institute at St. John's Hospital | Recruiting |
Springfield, Illinois, United States, 62702 | |
Contact: Stephen R. Hazelrigg, MD 217-545-8875 | |
Evanston Hospital | Recruiting |
Evanston, Illinois, United States, 60201-1781 | |
Contact: Clinical Trials Office - Evanston Hospital 847-570-1381 | |
Simmons Cooper Cancer Institute | Recruiting |
Springfield, Illinois, United States, 62794-9677 | |
Contact: Clinical Trials Office - Simmons Cooper Cancer Institute 217-545-7929 | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611-3013 | |
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu | |
Regional Cancer Center at Memorial Medical Center | Recruiting |
Springfield, Illinois, United States, 62781-0001 | |
Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me 217-788-4233 | |
United States, Indiana | |
Reid Hospital & Health Care Services | Recruiting |
Richmond, Indiana, United States, 47374 | |
Contact: Daniel P. McKellar, MD 937-832-9310 | |
St. Francis Hospital and Health Centers - Beech Grove Campus | Recruiting |
Beech Grove, Indiana, United States, 46107 | |
Contact: Daniel P. McKellar, MD 937-832-9310 | |
United States, Maryland | |
Cancer Institute at St. Joseph Medical Center | Recruiting |
Towson, Maryland, United States, 21204 | |
Contact: Linda W. Martin 410-337-1000 | |
United States, Michigan | |
Josephine Ford Cancer Center at Henry Ford Hospital | Recruiting |
Detroit, Michigan, United States, 48202 | |
Contact: S. David Nathanson, MD 313-916-2917 | |
United States, Ohio | |
CCOP - Dayton | Recruiting |
Dayton, Ohio, United States, 45429 | |
Contact: Daniel P. McKellar, MD 937-832-9310 | |
Blanchard Valley Medical Associates | Recruiting |
Findlay, Ohio, United States, 45840 | |
Contact: Daniel P. McKellar, MD 937-832-9310 | |
Bethesda North Hospital | Recruiting |
Cincinnati, Ohio, United States, 45242 | |
Contact: J. Michael Smith, MD 513-872-6915 | |
Charles F. Kettering Memorial Hospital | Recruiting |
Kettering, Ohio, United States, 45429 | |
Contact: Clinical Trials Office - Charles F. Kettering Memorial Hospita 937-298-3399 ext. 57556 | |
Clinton Memorial Hospital | Recruiting |
Wilmington, Ohio, United States, 45177 | |
Contact: Daniel P. McKellar, MD 937-832-9310 | |
Good Samaritan Hospital Cancer Treatment Center | Recruiting |
Cincinnati, Ohio, United States, 45220 | |
Contact: J. Michael Smith, MD 513-872-6915 | |
Good Samaritan Hospital | Recruiting |
Dayton, Ohio, United States, 45406 | |
Contact: Daniel P. McKellar, MD 937-832-9310 | |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Recruiting |
Xenia, Ohio, United States, 45385 | |
Contact: Daniel P. McKellar, MD 937-832-9310 | |
Middletown Regional Hospital | Recruiting |
Franklin, Ohio, United States, 45005-1066 | |
Contact: Daniel P. McKellar, MD 937-832-9310 | |
Grandview Hospital | Recruiting |
Dayton, Ohio, United States, 45405 | |
Contact: Daniel P. McKellar, MD 937-832-9310 | |
Samaritan North Cancer Care Center | Recruiting |
Dayton, Ohio, United States, 45415 | |
Contact: Daniel P. McKellar, MD 937-832-9310 | |
UVMC Cancer Care Center at Upper Valley Medical Center | Recruiting |
Troy, Ohio, United States, 45373-1300 | |
Contact: Clinical Trials Office - UVMC Cancer Care Center at Upper Vall 937-440-4842 | |
Wayne Hospital | Recruiting |
Greenville, Ohio, United States, 45331 | |
Contact: Daniel P. McKellar, MD 937-832-9310 | |
United States, Oregon | |
Providence Cancer Center at Providence Portland Medical Center | Recruiting |
Portland, Oregon, United States, 97213-2967 | |
Contact: Clinical Trials Office - Providence Cancer Center at Providenc 503-215-6412 | |
United States, Pennsylvania | |
York Cancer Center at Apple Hill Medical Center | Recruiting |
York, Pennsylvania, United States, 17405 | |
Contact: Ronald E. Hempling, MD 717-741-8100 | |
United States, Rhode Island | |
Rhode Island Hospital Comprehensive Cancer Center | Recruiting |
Providence, Rhode Island, United States, 02903 | |
Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C 401-444-1488 |
Study Chair: | Carolyn E. Reed, MD | Medical University of South Carolina |
Responsible Party: | American College of Surgeons Oncology Group ( David M. Ota ) |
Study ID Numbers: | CDR0000596674, ACOSOG-Z4051 |
Study First Received: | September 22, 2008 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00757172 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the esophagus adenocarcinoma of the gastroesophageal junction stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer |
Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Esophageal Cancer Carcinoma Docetaxel Digestive System Diseases Radiation-Sensitizing Agents |
Cisplatin Esophageal Disorder Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Digestive System Neoplasms Antineoplastic Agents Gastrointestinal Diseases Esophageal Neoplasms Physiological Effects of Drugs Pharmacologic Actions Carcinoma Docetaxel Neoplasms |
Digestive System Diseases Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |