Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00400114
First received: November 15, 2006
Last updated: September 9, 2014
Last verified: September 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Sutent Following Chemotherapy, Radiation and Surgery For Esophageal Cancer, A Phase II Trial (ASSET)

Resource links provided by NLM:


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. [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

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 [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
  • To characterize toxicity of targeted adjuvant therapy with Sutent after multimodality therapy for resected esophageal cancer stage II to III [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]
  • To measure time-to-event efficacy variables including: Time to treatment failure and Time to progressive disease [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
  • Survival of patients with esophageal cancer stage II to III with adjuvant targeted therapy added to multimodality treatment protocol [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
  • To determine the pattern of relapse (local versus distant) with the addition of adjuvant targeted therapy to esophageal cancer multimodality therapy [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: November 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sunitinib Drug: Irinotecan
Irinotecan (50mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8
Drug: Cisplatin
Cisplatin (65mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8
Procedure: Radiation
Radiation 50 Gy (weeks 4-9)
Procedure: Surgery
Esophagectomy
Drug: sunitinib (Sutent)
sunitinib (Sutent), dose range of 12.5mg - 50mg OD x 1 year post op.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400114

Locations
Canada, Ontario
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
University Health Network (Princess Margaret & Toronto General Hospitals)
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Pfizer
Investigators
Principal Investigator: Jennifer J Knox, MD M.Sc. FRCPC University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00400114     History of Changes
Other Study ID Numbers: 06-0407-C
Study First Received: November 15, 2006
Last Updated: September 9, 2014
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Irinotecan
Sunitinib
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014