Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Durvalumab

Antineoplastic Agents, Immunological

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.

Shadia Jalal, M.D.

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.

OUTLINE: This is a multi-center trial.

INVESTIGATIONAL TREATMENT:

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:

Hematopoietic:

* 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

Renal:

* Calculated creatinine clearance of \>/= 40 cc/min using the Cockcroft-Gault formula or by 24-hour urine collection.

Hepatic:

* 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

A Study of Durvalumab (MEDI4736) in Esophageal Cancer

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

Relapse free survival is defined as time from the date of surgery until the criteria for disease relapse is met, per Response Evaluation Criteria In Solid Tumors (RECIST 1.1), or death occurs.

Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started The percentage of subjects who attained relapse free survival for 1 year and 95 % confidence interval has been reported here.

One of the secondary objective in this study is to assess toxicity and tolerability of durvalumab following trimodality therapy in patients with esophageal cancer. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.

Adverse Event severity grades can be described as follows :

* Grade 1 indicates a mild event
* Grade 2 indicates a moderate event
* Grade 3 indicates a severe event
* Grade 4 indicates a potentially life-threatening event
* Grade 5 indicates death

MedImmune LLC

AstraZeneca

Big Ten Cancer Research Consortium

Shadia Jalal, MD

Sponsor-Investigator

Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.

Investigational Treatment

Age, Customized

Sex: Female, Male

Race

Race/Ethnicity, Customized

Ethnicity

Site

Site of Disease

Chemotherapy Regimen

This population includes all subjects who were enrolled and found eligible and evaluable for this trial.

Annesha Majumdar

Percentage of Participants With One-Year Relapse Free Survival (RFS) With Post-Operative Durvalumab

Patient had at least one adverse event of any grade

Patient had at least one grade 3 or greater adverse event

Patient had at least one grade 3 or greater treatment related adverse event

Patient having serious adverse event

Number of Patients With Adverse Events as a Measure of Safety and Tolerability

Relapse free survival is defined as time from the date of surgery until the criteria for disease relapse is met, per Response Evaluation Criteria In Solid Tumors (RECIST 1.1), or death occurs.

Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Here Median Relapse Free Survival time in months has been reported.

Median Relapse Free Survival.

Study Treatment

Follow up

Spots Global Cancer Trial Database for A Study of Durvalumab (MEDI4736) in Esophageal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial