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

Esophageal Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01035437
• Other study ID #: RPCI I 148809
• Status: Withdrawn
• Phase: N/A
• First received: December 17, 2009
• Last updated: June 28, 2012
• Start date: December 2009
• Est. completion date: February 2011

Study information

• Verified date: June 2012
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasm
• Esophageal Neoplasms

Intervention

Drug:
• HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a)
HPPH in D5W, 4.0 mg/m2 infused over 1 hour

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the toxicity of sequential PDT and chemoradiation in obstructing esophageal cancer		2 year	Yes
Secondary	Evaluate the efficacy of PDT in palliation of dysphagia		2 years	Yes