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This study has been withdrawn prior to enrollment.
(no accrual)
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01035437
First received: December 17, 2009
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention
Esophageal Neoplasm
Drug: HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a)

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

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Determine the toxicity of sequential PDT and chemoradiation in obstructing esophageal cancer [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the efficacy of PDT in palliation of dysphagia [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: December 2009
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HPPH
HPPH
Drug: HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a)
HPPH in D5W, 4.0 mg/m2 infused over 1 hour

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035437

Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Nikhil Khushalani, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01035437     History of Changes
Other Study ID Numbers: RPCI I 148809
Study First Received: December 17, 2009
Last Updated: June 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
obstructing

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 19, 2014