Testing the Addition of an Anti-cancer Drug, Adavosertib, to Radiation Therapy for Patients With Incurable Esophageal and Gastroesophageal Junction Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Clinical Stage III Esophageal Adenocarcinoma AJCC v8
- Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8
- Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Metastatic Esophageal Squamous Cell Carcinoma
- Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
- Metastatic Malignant Neoplasm in the Leptomeninges
- Unresectable Esophageal Squamous Cell Carcinoma
- Gastric Cardia Adenocarcinoma
- Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Metastatic Gastroesophageal Junction Adenocarcinoma
- Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Unresectable Esophageal Carcinoma
- Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
- Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
- Distal Esophagus Adenocarcinoma
- Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IV Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8
- Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8
- Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
- Metastatic Esophageal Adenocarcinoma
- Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8
- Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8
- Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
- Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8
- Unresectable Esophageal Adenocarcinoma
- Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8
- Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8
- Unresectable Gastroesophageal Junction Adenocarcinoma
- Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
- Metastatic Malignant Neoplasm in the Brain
- Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
- Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
- Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To identify the maximally tolerated dose of adavosertib (AZD1775) to be used in combination with radiation therapy for patients with esophageal/gastroesophageal junction (GEJ) cancer that is metastatic or inoperable and not eligible for definitive chemoradiation. SECONDARY OBJE...
PRIMARY OBJECTIVE: I. To identify the maximally tolerated dose of adavosertib (AZD1775) to be used in combination with radiation therapy for patients with esophageal/gastroesophageal junction (GEJ) cancer that is metastatic or inoperable and not eligible for definitive chemoradiation. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. To evaluate the efficacy of AZD1775 when administered in combination with radiation therapy by assessing changes in Ogilvie dysphagia score following treatment, time to second intervention for dysphagia, and overall survival. III. To identify biomarkers that are predictive for response to experimental therapy. OUTLINE: This is a dose escalation study of adavosertib. Patients undergo radiation therapy once daily (QD) 5 days per week for 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive adavosertib orally (PO) QD for 2-5 days (depending on dose level) during weeks 1 and 3 of radiation therapy in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3 weeks, every 3 months for 2 years, then every 6 months for 3 years.
Tracking Information
- NCT #
- NCT04460937
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Eric D Miller Ohio State University Comprehensive Cancer Center LAO