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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

Primary Purpose

Esophageal Neoplasm

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a)
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Neoplasm focused on measuring obstructing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HPPH

    Arm Description

    HPPH

    Outcomes

    Primary Outcome Measures

    Determine the toxicity of sequential PDT and chemoradiation in obstructing esophageal cancer

    Secondary Outcome Measures

    Evaluate the efficacy of PDT in palliation of dysphagia

    Full Information

    First Posted
    December 17, 2009
    Last Updated
    June 28, 2012
    Sponsor
    Roswell Park Cancer Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01035437
    Brief Title
    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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no accrual
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    February 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Roswell Park Cancer Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Neoplasm
    Keywords
    obstructing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HPPH
    Arm Type
    Experimental
    Arm Description
    HPPH
    Intervention Type
    Drug
    Intervention Name(s)
    HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a)
    Intervention Description
    HPPH in D5W, 4.0 mg/m2 infused over 1 hour
    Primary Outcome Measure Information:
    Title
    Determine the toxicity of sequential PDT and chemoradiation in obstructing esophageal cancer
    Time Frame
    2 year
    Secondary Outcome Measure Information:
    Title
    Evaluate the efficacy of PDT in palliation of dysphagia
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nikhil Khushalani, MD
    Organizational Affiliation
    Roswell Park Cancer Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    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

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