Study of Adjuvant Regorafenib vs Placebo in Patients With Node Positive Esophageal Cancer That Completed Pre-operative Therapy

Description

The purpose of this research study is to find out what effects, good and/or bad, the drug regorafenib has on stomach or esophagus cancer after completion standard chemotherapy, radiation therapy and surgery prescribed by your doctor. In this study the participant will either get regorafenib or a "placebo".

Study Start Date

September 2014

Estimated Completion Date

October 2020

Interventions

  • Drug: Placebo
  • Drug: Regorafenib

Specialties

  • Gastroenterology: Esophagus,GI Oncology
  • Oncology: GI Oncology

MeSH Terms

  • Esophageal Neoplasms
  • Regorafenib

Study ID

Academic and Community Cancer Research United -- RU021212I

Status

Unknown

Trial ID

NCT02234180

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

105

Sponsor

Academic and Community Cancer Research United

Inclusion Criteria

  • Histological confirmation of node positive (any T stage N1-3) proximal esophageal, distal esophagus or gastroesophageal (GE) junction adenocarcinoma (Siewert I, II, or III) after completing preoperative chemoradiation and surgery. Supporting pathology report sufficient for registration. Available tumor tissue from endoscopic biopsies prior to preoperative chemo/RT, and tumor from surgical specimens will be submitted to the sponsor, but are not required prior to registration. Note: if tissue is depleted, patient will still be eligible after discussion with the physician.
  • Imaging (CT or MRI) ? 28 days of study registration negative for disease recurrence
  • ECOG Performance Status (PS) 0 or 1
  • The following laboratory values obtained ? 28days prior to randomization Absolute neutrophil count (ANC) ?1500/mm3 Platelet count >=100,000/mm3 Total bilirubin ?1.5 x the upper limits of normal (ULN) Alanine aminotransferase (ALT) and aspartate amino-transferease (AST) ? 2.5 x ULN (? 5 x ULN for subjects with liver involvement of their cancer) Alkaline phosphastase limit ? 2.5 x ULN (? 5 x ULN for subjects with liver involvement of their cancer) Lipase ? 1.5 x the ULN Serum creatinine ? 1.5 x the ULN INR/PTT <=1.5xULN. Note-Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that their medication dose and INR/PTT are stable. Close monitoring (day 1 of each cycle) is mandatory. If either of these values is above the therapeutic range, the doses should be modified and the assessments should be repeated weekly until they are stable
  • Negative pregnancy test done ?7 days prior to registration, for women of childbearing potential only
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  • Able to swallow and retain oral medications and begin therapy within 6 to 12 weeks post-surgery
  • Provide blood samples for the mandatory correlative research purposes (see sections 6.12 and 14.0)

Exclusion Criteria

  • Presence of metastatic or recurrent disease
  • R1 or R2 resection
  • Patients who have not recovered from serious adverse events (as determined by treating MD) related to surgery
  • Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg on repeated measurement) despite optimal medical management per physician discretion
  • Active or clinically significant cardiac disease including: Congestive heart failure
  • New York Heart Association (NYHA) > Class II. Active coronary artery disease Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin Unstable angina (anginal symptoms at rest), new-onset angina <3 months before randomization, or myocardial infarction within 6 months before randomization.
  • Evidence or history of bleeding diathesis or coagulopathy
  • Any hemorrhage or bleeding event ? NCI CTCAE Version 4 Grade 3 ? 4 weeks prior to registration
  • Prior cancers < 3 years, with the exception of in-situ cervical cancer, low grade prostate cancer and basal or squamous cell skin cancers.
  • Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism ? 6 months prior to registration
  • Receiving any medications or substances that are strong or moderate inhibitors of CYP3A4
  • Use of the following strong or moderate inhibitors are prohibited < 7 days prior to registration
  • Receiving any medications or substances that are inducers of CYP3A4

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (11)

Study Location Distance Name Phone Email
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles Crystallee J Newton BA CCRC 603-650-4428 Crystallee.J.Newton@Hitchcock.org
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Yelena Janjigian 646-888-4186 None
Roswell Park Cancer Institute - Buffalo, New York 397.2 miles None None None
The Ohio State University - Columbus, Ohio 641.8 miles Alison M Neal 614-293-3657 Alison.neal@osumc.edu
Toledo Community Hospital Oncology Program CCOP - Toledo, Ohio 650.4 miles Pamela Shoup 419-843-6147 None
Wake Forest University Health Sciences - Winston-Salem, North Carolina 659.2 miles Jennifer Black 336-716-9342 None
Carle Cancer Center - Urbana, Illinois 902.4 miles Carle Cancer Center Research 217-383-3516 Cancer.Resaerch@Carle.com
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Clinical Trials Referral Office 855-776-0015 None
Missouri Valley Cancer Consortium CCOP - Omaha, Nebraska 1,283.4 miles Ralph Hauke None drhauke@nebraskacancer.com
Missouri Valley Cancer Consortium - Omaha, Nebraska 1,283.4 miles Mary Beth Wilwerding RN 402-991-8070 mwilwerding@mvcc.cc
Cancer Center of Kansas - Wichita, Kansas 1,421.3 miles Pat Stone RN 316-262-4467 pat.stone@cancercenterofkansas.com

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