Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer

NCT00400114 | Completed Phase 2

• 1 other identifier: 06-0407-C
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Esophageal Cancer

Keywords

esophageal; esophagus; cancer; sutent; sunitinib

Outcome Measures

Primary Outcomes (1)

• 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.

  5 yrs

Secondary Outcomes (5)

• 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

  5 yrs

• To characterize toxicity of targeted adjuvant therapy with Sutent after multimodality therapy for resected esophageal cancer stage II to III

  2 yrs

• To measure time-to-event efficacy variables including: Time to treatment failure and Time to progressive disease

  5 yrs

• Survival of patients with esophageal cancer stage II to III with adjuvant targeted therapy added to multimodality treatment protocol

  5 yrs

• To determine the pattern of relapse (local versus distant) with the addition of adjuvant targeted therapy to esophageal cancer multimodality therapy

  5 yrs

Study Arms (1)

sunitinib

EXPERIMENTAL

Drug: Irinotecan; Drug: Cisplatin; Procedure: Radiation; Procedure: Surgery; Drug: sunitinib (Sutent)

Interventions

Irinotecan DRUG

Irinotecan (50mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8

sunitinib

Cisplatin DRUG

Cisplatin (65mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8

sunitinib

Radiation PROCEDURE

Radiation 50 Gy (weeks 4-9)

sunitinib

Surgery PROCEDURE

Esophagectomy

sunitinib

sunitinib (Sutent) DRUG

sunitinib (Sutent), dose range of 12.5mg - 50mg OD x 1 year post op.

sunitinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Pfizer: collaborator

Study Sites (2)

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network (Princess Margaret & Toronto General Hospitals)

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• Horgan AM, Darling G, Wong R, Guindi M, Liu G, Jonker DJ, Lister J, Xu W, MacKay HM, Dinniwell R, Kim J, Pierre A, Shargall Y, Asmis TR, Agboola O, Seely AJ, Ringash J, Wells J, Marginean EC, Haider M, Knox JJ. Adjuvant sunitinib following chemoradiotherapy and surgery for locally advanced esophageal cancer: a phase II trial. Dis Esophagus. 2016 Nov;29(8):1152-1158. doi: 10.1111/dote.12444. Epub 2015 Dec 10.

  PMID: 26663741 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Neoplasms

Interventions

Irinotecan; Cisplatin; Radiation; Surgical Procedures, Operative; Sunitinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jennifer J Knox, MD M.Sc. FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2006
• First Posted: November 16, 2006
• Study Start: September 25, 2006
• Primary Completion: September 19, 2016
• Study Completion: September 19, 2016
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

CA (2)