A Study of Durvalumab (MEDI4736) in Esophageal Cancer
This is a phase II, open-label, single arm, single-stage study. A total of 23 evaluable patients will be enrolled. If total number of patients free of disease relapse at 1 year is less than or equal to 15, the drug would not be considered for further study in this setting. After six patients are treated with at least one dose of study drug, they will be observed for a minimum of 60 days. During the 60-day observation period, further accrual will be halted to evaluate "unacceptable toxicities warranting early closure of the trial" defined as:
- Any definitive durvalumab-related death. A durvalumab-related death will be continuously monitored throughout the trial and the trial will be suspended for re-evaluation whenever such an event is confirmed.
- Any unexpected and previously unreported grade 4 toxicities definitely related to durvalumab.
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Open LabelPrimary Purpose: Treatment
|Official Title:||A Phase II Study Evaluating Safety and Efficacy of Durvalumab (MEDI4736) Following Multi-modality Therapy in Esophageal Cancer: Big Ten Cancer Research Consortium BTCRC-ESO14-012|
- One-Year Relapse Free Survival (RFS) Rates with Post-Operative Adjuvant Durvalumab [ Time Frame: Assessed at one year post-surgery ]RFS defined as time from the date of surgery until criteria for disease relapse is met, per Response Evaluation Criteria In Solid Tumors (RECIST 1.1), or death occurs
- Number of Patients with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From time of consent and up to 90 days after treatment discontinuation (est. 15 months) ]Assess toxicity and tolerability of durvalumab following trimodality therapy, per Common Terminology Criteria for Adverse Events (CTCAE) v4
|Study Start Date:||April 2016|
|Estimated Study Completion Date:||May 2019|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Experimental: Investigational Treatment
Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
Other Name: MEDI4736
OUTLINE: This is a multi-center trial.
Subjects will receive durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
The following baseline labs must be completed within 28 days prior to registration for protocol therapy:
- White blood cell count (WBC) > 3 K/mm^3
- Hemoglobin (Hgb) > 9 g/dL. Transfusion is allowed, if needed, since patients are post esophagectomy.
- Platelets > 100 K/mm^3
- Absolute neutrophil count (ANC) ≥ 1.5 K/mm^3
- Calculated creatinine clearance of >/= 40 cc/min using the Cockcroft-Gault formula or by 24-hour urine collection.
- Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST, SGOT) </= 2.5 x ULN
- Alanine aminotransferase (ALT, SGPT) </= 2.5 x ULN
Please refer to this study by its ClinicalTrials.gov identifier: NCT02639065
|Contact: Shadia Jalal, M.D.||firstname.lastname@example.org|
|Contact: Ahran Lee||317.634.5842 ext email@example.com|
|United States, Illinois|
|University of Illinois Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Mary Hidde 312-413-1069 firstname.lastname@example.org|
|Principal Investigator: Rozina Chowhery, MD|
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Shadia Jalal, M.D. 317-278-8845 email@example.com|
|Contact: Maggie Uhrich 317.274.4505 firstname.lastname@example.org|
|United States, Iowa|
|Unversity of Iowa Hospital and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Janelle Born 319-356-4797 email@example.com|
|Principal Investigator: Laith Abushahin, MD|
|United States, Michigan|
|University of Michigan Health System||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Maria Moreno-Rollins 734-647-2148 firstname.lastname@example.org|
|Principal Investigator: Bryan Schneider, MD|
|Michigan State University||Recruiting|
|Lansing, Michigan, United States, 48910|
|Contact: Karen Luellen 517-975-9534 Karen.Luellen@hc.msu.eduu.edu|
|Principal Investigator: Borys Hrinczenko, M.D.|
|Study Chair:||Shadia Jalal, M.D.||Big Ten Cancer Research Consortium|