A Pilot Study for Determination of Feasibility and Toxicity of Pre-Treatment With HPPH (2-1[1-Hexyloxyethyl]-2 Devinyl Pyropheophorbide-a) Photodynamic Therapy Prior to Chemoradiation in Non-Operable Patients With Obstructive Esophageal Cancer

Overview

Phase: Not Applicable
Intervention: HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a)
Conditions: Esophageal Neoplasm
Sponsor: Roswell Park Cancer Institute
Primary Endpoint: Determine the toxicity of sequential PDT and chemoradiation in obstructing esophageal cancer
Status: Withdrawn
Last Updated: 13 years ago

This study aim is to find out what effects capecitabine, oxaliplatin and radiation therapy following photodynamic therapy have on esophageal cancer.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

February 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•Partially or completely obstructing primary esophageal carcinoma, clinical stage I-IVa as determined by endoscopy, CT-scan, PET +/- endoscopic ultrasound. For distal esophagus tumors involving the GE junction, at least 50% or greater of the tumor bulk should be in the distal esophagus
•Ineligible for or refused surgical resection
•No Prior therapy allowed for esophageal cancer
•ECOG Performance status 0-1
•Life expectancy \> 4 months
•Adequate hematologic parameters (hemoglobin\> 9g/dl, ANC \> 1500/ul, Platelets \> 100,000/ul)
•Adequate biochemical parameters (total bilirubin and creatinine within institutional limits, AST and alkaline phosphatase less tham or equal to 3xUNL)
•Age \> 18 years
•Signed informed consent
•Bronchoscopy with biopsy and cytology if primary esophageal cancer is \< 26 cm from incisors

•Hypersensitivity to platinum compounds, fluoropyrimidines or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
•Patients may not be receiving any other investigational agents
•Patients with known brain metastases should be excluded from this trail
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements
•Peripheral neuropathy ≥ Grade 2
•History of second malignancy within the previous years except for curatively treated carcinoma of the cervix in-situ or non-melanomatous skin cancer
•Patients who are pregnant or lactating
•Porphyria or hypersensitivity to porphyrin-like compounds
•Patients with known HIV or Hepatitis B or C (active, previously treated or both)
•Patients with tracheal or bronchial involvement, as determined by bronchoscopy