Testing TH-302, in Combination With Preoperative Chemoradiotherapy, in Esophageal Cancer.

• Status: Withdrawn
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Open-label, single-center phase 1 study of an investigational agent TH-302 and standard chemoradiotherapy with a 3+3 dose escalation design through 3 dose levels.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht Radiation Oncology
• Collaborators: Threshold Pharmaceuticals; Zuyderland Medical Centre
• Treatments: Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically proven adenocarcinoma of the esophagus

• Age >18 years

• UICC T2-4 N0-2 M0, potentially resectable disease

• Patient discussed at tumour board (multidisciplinary team meeting)

• No evident tumor invasion in nearby regions like aorta or trachea

• WHO performance status 0-2

• Less than 10 % weight loss in the past 6 months

• Laboratory requirements within 7 days prior to enrollment (start chemoradiotherapy):

• Haematology:

• haemoglobin >10g/dl

• absolute neutrophils ≥ 1.5 x 109/L

• platelets ≥ 100x109/L

• Biochemistry:

• bilirubin within institutional normal limits

• AST(SGOT)/ALT (SGPT) ≤ 2.5 institutional upper limit

• Creatinine clearance ≥ 60 ml/min

• Willing and able to comply with the study prescriptions

• No history of prior thoracic radiotherapy

• No severe chronic obstructive pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state leading to hypoxemia

• Women should not be pregnant or lactating

• No known infection with HIV, hepatitis B or C or any other active infection

• Normal ECG with careful evaluation of QT/QTc

• Have given written informed consent before patient registration

Exclusion Criteria:

• Recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)

• Patients with difficult peripheral intravenous access

• History of prior thoracic radiotherapy

• severe chronic obstructive pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state leading to hypoxemia

• Women who are pregnant or lactating

• Known infection with HIV, hepatitis B or C or any other active infection