Ultrasound-Guided Photodynamic Therapy With Photofrin & Gemcitabine for Patients With Locally Advanced Pancreatic Cancer

NCT01770132 | Completed Phase 1 DMC

• 2 other identifiers: IUCRO-03191207009096
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of ultrasound-guided photodynamic therapy with porfimer sodium when given together with gemcitabine hydrochloride in treating patients with locally advanced pancreatic cancer. Photodynamic therapy uses a drug, porfimer sodium, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving photodynamic therapy together with gemcitabine hydrochloride may be effect in patients with pancreatic cancer.

Conditions

Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Stage III Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate the number of subjects with adverse events which occur when up to 3 sites within the pancreas are treated with PDT using a total dose of 50 or 100 J per site

  Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 which uses a scale of 1 (mild) to 5 (caused death).

  Up to 4 years

Secondary Outcomes (7)

• CT- or MRI-detected volume of tumor necrosis

  Week 2

• Rates of tumor size stabilization or decease by EUS-PDT

  Up to 4 years

• Objective response rate per RECIST

  Up to 4 years

• Surgical downstaging off of abdominal vessels or change in tumor unresectability

  Up to 4 years

• Change in CA 19-9 levels

  Baseline to up to 4 years

Study Arms (1)

porfimer sodium, EUS-PDT, gemcitabine

EXPERIMENTAL

Patients receive porfimer sodium IV over 3-5 minutes on day 1 and undergo endoscopic ultrasonography-photodynamic therapy (EUS-PDT) on days 1, 3, 8, and 21. After completion of EUS-PDT, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 of courses 1 and 2 and on day 22 of courses 3 and 5. During courses 1-5, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After course 5, treatment with gemcitabine hydrochloride repeats every 2 months in the absence of disease progression or unacceptable toxicity.

Drug: porfimer sodium; Procedure: endoscopic ultrasonography; Procedure: photodynamic therapy; Drug: gemcitabine hydrochloride

Interventions

porfimer sodium DRUG

Given IV

Also known as: Photofrin, Photofrin II, Porfimer

porfimer sodium, EUS-PDT, gemcitabine

endoscopic ultrasonography PROCEDURE

Undergo EUS-PDT

Also known as: endoscopic ultrasound, EUS

porfimer sodium, EUS-PDT, gemcitabine

photodynamic therapy PROCEDURE

Undergo EUS-PDT

Also known as: Light Infusion Therapy, PDT, therapy, photodynamic

porfimer sodium, EUS-PDT, gemcitabine

gemcitabine hydrochloride DRUG

Given IV

Also known as: gemcitabine, Gemzar, LY-188011

porfimer sodium, EUS-PDT, gemcitabine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Unresectable, locally advanced measurable (at least bidirectional) adenocarcinoma of the pancreas (regardless of site) proven by biopsy or cytology and confirmed by surgical consultation
• Informed consent and authorization for the release of health information signed by the patient
• Karnofsky performance status \>= 70%
• Life expectancy \>= 3 months
• Females of childbearing potential and males must use an effective method of contraception

You may not qualify if:

• Metastatic (stage IV) disease (including involvement of the colon, adrenals, or kidney, or radiographic evidence of peritoneal seeding or pulmonary metastases)
• Previous chemotherapy, radiotherapy of other treatment for PC
• Gastric or duodenal wall invasion by the primary PC as assessed by CT or MRI and EUS staging
• Gastric or duodenal ulcer (at least 10 mm in size) within 10 mm of expected endoscopy puncture site(s) for PDT
• Esophageal or gastric varices
• Cystic component \>= 25% the total volume of the tumor
• Bulky celiac adenopathy (i.e., \>= 2.5 cm in diameter)
• Diagnosis of islet cell tumor, lymphoma, metastatic lesion, acinar cell (or other atypical pathologic malignancy)
• History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer or localized/early stage prostate cancer
• Unable to receive or previously intolerant of moderate and/or deep sedation
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>= 3 x upper limit of normal (ULN)
• Total bilirubin \>= 3 x ULN
• Alkaline phosphatase \>= 3 x ULN
• International normalized ratio (INR) \>= 1.5
• Partial thromboplastin time (PTT) ratio \>= 1.5

Sponsors & Collaborators

• John DeWitt: lead
• American Society for Gastrointestinal Endoscopy: collaborator
• Pinnacle Biologics Inc.: collaborator

Study Sites (1)

IU Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• DeWitt JM, Sandrasegaran K, O'Neil B, House MG, Zyromski NJ, Sehdev A, Perkins SM, Flynn J, McCranor L, Shahda S. Phase 1 study of EUS-guided photodynamic therapy for locally advanced pancreatic cancer. Gastrointest Endosc. 2019 Feb;89(2):390-398. doi: 10.1016/j.gie.2018.09.007. Epub 2018 Sep 14.

  PMID: 30222972 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Dihematoporphyrin Ether; Endoscopic Ultrasound-Guided Fine Needle Aspiration; Photochemotherapy; 1-phenyl-3,3-dimethyltriazene; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors; Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Study Officials

• John M DeWitt, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 17, 2013
• Study Start: April 19, 2013
• Primary Completion: July 13, 2017
• Study Completion: October 28, 2018
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

US (1)