Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer
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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) |
- 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 ]
- 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 Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
-
Drug: Irinotecan
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 |
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| 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 | |
| Principal Investigator: | Jennifer J Knox, MD M.Sc. FRCPC | University Health Network, Toronto |
More Information
No publications provided
| Responsible Party: | Dr. Jennifer Knox, University Health Network |
| ClinicalTrials.gov Identifier: | NCT00400114 History of Changes |
| Other Study ID Numbers: | 06-0407-C |
| Study First Received: | November 15, 2006 |
| Last Updated: | July 12, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
esophageal esophagus cancer sutent sunitinib |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Irinotecan Sunitinib Cisplatin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013