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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Esophageal Neoplasm
• Intervention / Treatment: Drug: HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a)

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• Female patients of childbearing potential should have a negative serum or urine pregnancy test within 7 days prior to registration
• Patients of Childbearing potential agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method
• Both men and women and members of all races and ethnic are eligible for this trial

Exclusion Criteria:

• 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
• Patients with documented unilateral or bilateral vocal cord paralysis
• Patients with T4 lesions by CT, MRI or EUS involving the aorta, lung or pericardium

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HPPH	Drug: HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a); HPPH in D5W, 4.0 mg/m2 infused over 1 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the toxicity of sequential PDT and chemoradiation in obstructing esophageal cancer	2 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate the efficacy of PDT in palliation of dysphagia	2 years

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): February 1, 2011

Study Registration Dates

• First Submitted: December 17, 2009
• First Submitted That Met QC Criteria: December 17, 2009
• First Posted (ESTIMATE): December 18, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 2, 2012
• Last Update Submitted That Met QC Criteria: June 28, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: obstructing
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: RPCI I 148809