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Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer
This study is currently recruiting participants.
Verified by University Health Network, Toronto, February 2007
Sponsors and Collaborators: University Health Network, Toronto
Pfizer
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00400114
  Purpose

The purpose of this study is to see whether or not the combination of cisplatin, irinotecan and radiation, followed by surgery, followed by oral Sutent, is effective and safe for patients with resectable esophageal cancer.


Condition Intervention Phase
Esophageal Cancer
Drug: Irinotecan
Drug: Cisplatin
Procedure: Radiation
Procedure: Surgery
Drug: sunitinib (Sutent)
Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders
Drug Information available for: Cisplatin Irinotecan Irinotecan hydrochloride Sunitinib Sunitinib malate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Adjuvant Sutent Following Chemotherapy, Radiation and Surgery For Esophageal Cancer, A Phase II Trial (ASSET)

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To determine the feasibility and efficacy of adjuvant Sutent therapy after concurrent neoadjuvant therapy with Irinotecan, Cisplatin, external beam conformal radiotherapy plus surgery for potentially resectable esophageal cancer.

Secondary Outcome Measures:
  • To assess the impact of adjuvant targeted therapy with Sutent after multimodality therapy for resected esophageal cancer stage II to III, and to compare these data to our current completed trial in the same patient population
  • To characterize toxicity of targeted adjuvant therapy with Sutent after multimodality therapy for resected esophageal cancer stage II to III
  • To measure time-to-event efficacy variables including: Time to treatment failure and Time to progressive disease
  • Survival of patients with esophageal cancer stage II to III with adjuvant targeted therapy added to multimodality treatment protocol
  • To determine the pattern of relapse (local versus distant) with the addition of adjuvant targeted therapy to esophageal cancer multimodality therapy

Estimated Enrollment: 36
Study Start Date: November 2006
Detailed Description:

Survival outcomes for resectable esophageal cancer remain poor. Current data strongly support an adjuvant systemic strategy to improve time to progression and survival in this patient population. Adding a well-tolerated oral targeted therapy such as Sutent, after a combined chemo/radiation/surgery approach in this patient population has the potential to impact on the minimal residual disease left behind by relatively effective pre-operative chemoradiation and surgery. This has the potential to improve survival. The primary endpoint is to determine the feasibility and efficacy of adjuvant Sutent therapy (SU11248) after concurrent neoadjuvant therapy with irinotecan, cisplatin, external beam conformal radiotherapy plus surgery for potential resectable esophageal cancer. Preclinical and clinical data suggest that Sutent will have activity in esophageal cancer, as the results of Sutent activity in solid tumors appear to be superior to the results of other antiangiogenic compounds in development for esophageal cancer. Therefore, by extrapolation from promising phase I, II and III Sutent trials we propose to translate the target effects achieved with Sutent to reduce local and systemic therapy failure, and thus metastasis in esophageal cancer.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven squamous or adenocarcinoma or the esophagus >20 cm from the incisors, including GE junction tumors (unless of gastric origin).
  • Tumors must be technically resectable.
  • Clinical T1N1M0, T2-3 N0-1 M0
  • Performance status ECOG 0-1
  • Medically fit for chemotherapy, radiation and esophagectomy

Exclusion Criteria:

  • In situ or clinical T1N0M0, and stage IV (M1a orM1b)
  • Cervical esophageal tumors (within 20 cm of the incisors)
  • Age <18 or >70
  • Participation in another concurrent clinical study involving study drug(s) or treatment with study drug within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy
  • known or suspected drug or alcohol abuse
  • Prior treatment for this malignancy except esophageal stenting
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400114

Contacts
Contact: Jennifer Hornby, BSc CCRP 416-340-4857 Jennifer.Hornby@uhn.on.ca

Locations
Canada, Ontario
University Health Network (Princess Margaret & Toronto General Hospitals) Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Jennifer K Hornby, BSc CCRP     416-340-4857     Jennifer.Hornby@uhn.on.ca    
Principal Investigator: Jennifer Knox, MD            
The Ottawa Hospital Regional Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Derek Jonker, MD     613-737-7700 ext 70168     djonker@ottawahospital.on.ca    
Principal Investigator: Derek Jonker, MD            
Sponsors and Collaborators
University Health Network, Toronto
Pfizer
Investigators
Principal Investigator: Jennifer J Knox, MD M.Sc. FRCPC University Health Network, Toronto
  More Information

Study ID Numbers: 06-0407-C
Study First Received: November 15, 2006
Last Updated: February 28, 2007
ClinicalTrials.gov Identifier: NCT00400114  
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
esophageal
esophagus
cancer
sutent
sunitinib

Study placed in the following topic categories:
Digestive System Neoplasms
Digestive System Diseases
Cisplatin
Esophageal disorder
Sunitinib
Gastrointestinal Diseases
Head and Neck Neoplasms
Esophageal Neoplasms
Irinotecan
Gastrointestinal Neoplasms
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009