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Acinar Cell Adenocarcinoma of the PancreasPhase 1NCT01770132

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

A Phase 1 study testing porfimer sodium, endoscopic ultrasonography and photodynamic therapy in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by John DeWitt at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
porfimer sodium, endoscopic ultrasonography and photodynamic therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
19 Apr 2013to 28 Oct 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 33Show fewer
  • Ascites detected by CT, ultrasound (US) or MRI; (trace ascites will not be an exclusion)
  • 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
  • Serum creatinine >= 2.0 mg/dL
  • Hematocrit =< 28% or hemoglobin =< 9 g/dL, but may have red blood cell (RBC) transfusion
  • Platelet count =< 100,000/microliter (uL)
  • Absolute neutrophil count (ANC) =< 1500/uL
  • Clinically significant pancreatitis within 12 weeks of treatment with protocol therapy
  • Contraindication to EUS-guided needle puncture into the pancreas
  • History of coagulopathy or known thrombophilias
  • Use of anticoagulants that cannot be discontinued both 5 days before and 5 days after EUS
  • Clinical evidence of active infection of any type, including hepatitis B or C virus
  • Pregnant or lactating women
  • Experimental medications within the last 4 weeks prior to day 1
  • Any surgery (including diagnostic laparoscopy and/or biliary +/- duodenal palliative bypass for inoperable PC) within the 2 weeks prior to day 1 of study protocol
  • Chronic systemic corticosteroid use at superphysiologic doses (>= 10 mg prednisone per day or equivalent)
  • Inability to avoid exposure of skin or eyes to direct sunlight or bright indoor light for at least 30 days
  • Porphyria
  • Inability to obtain venous access in the antecubital region to administer PHO or sedation for endoscopy procedures
  • Significant concurrent medical or psychiatric illness which, in the opinion of the principal investigator would interfere with trial participation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • IU Simon Cancer Center

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Open-label, Single-center, Non-randomized, Phase I, Dose-ranging Study of Endoscopic Ultrasound (EUS) Guided Photodynamic Therapy (PDT) With Photofrin® in Locally Advanced Pancreatic Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the safety of increasing porfimer sodium (PHO) dose and total energy by endoscopic ultrasound (EUS)-guided photodynamic therapy (PDT) for locally advanced unresectable pancreatic cancer (PC) in humans.

SECONDARY OBJECTIVES:

  1. Quantify computed tomography (CT) detected volume of tumor necrosis produced by EUS-PDT.

II. Quantify rates of tumor size stabilization or decrease by EUS PDT and determine objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

III. Determine surgical downstaging off of abdominal vessels and resectability. IV. Determine changes in serum cancer antigen (CA) 19-9 levels with treatment. V. Evaluate progression-free and overall survival.

OUTLINE: This is a dose-escalation study of EUS-PDT with porfimer sodium.

Patients receive porfimer sodium intravenously (IV) on day 1 and undergo 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.

After completion of study treatment, patients are followed up periodically.

Being tested
porfimer sodium, endoscopic ultrasonography, photodynamic therapy, gemcitabine hydrochloride
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • porfimer sodiumDrug

    Also called Photofrin, Photofrin II, Porfimer

    Given IV

  • endoscopic ultrasonographyProcedure or surgery

    Also called endoscopic ultrasound, EUS

    Undergo EUS-PDT

  • photodynamic therapyProcedure or surgery

    Also called Light Infusion Therapy, PDT, therapy, photodynamic

    Undergo EUS-PDT

  • gemcitabine hydrochlorideDrug

    Also called gemcitabine, Gemzar, LY-188011

    Given IV

Study groups in NCT01770132
Study groupRoleWhat they receive
porfimer sodium, EUS-PDT, gemcitabineExperimentalPatients 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.
Receives: Drug: porfimer sodium; Procedure: endoscopic ultrasonography; Procedure: photodynamic therapy; Drug: gemcitabine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 4 years

Secondary outcomes (7)

  1. CT- or MRI-detected volume of tumor necrosis

    Will be compared using paired t-tests or Wilcoxon rank sum tests as appropriate and changes will be plotted by maximal total energy of treatment to explore for dose-response effects.

    Measured: Week 2

  2. Rates of tumor size stabilization or decease by EUS-PDT

    Will be compared using paired t-tests or Wilcoxon rank sum tests as appropriate and changes will be plotted by maximal total energy of treatment to explore for dose-response effects.

    Measured: Up to 4 years

  3. Objective response rate per RECIST

    Measured: Up to 4 years

  4. Surgical downstaging off of abdominal vessels or change in tumor unresectability

    Measured: Up to 4 years

  5. Change in CA 19-9 levels

    Will be compared using paired t-tests or Wilcoxon rank sum tests as appropriate and changes will be plotted by maximal total energy of treatment to explore for dose-response effects.

    Measured: Baseline to up to 4 years

  6. Progression-free survival

    A Kaplan-Meier plot will be produced.

    Measured: From the date of initial treatment to the earliest date of disease progression, resection of measurable tumor or death for patients who fail; and to the date of disease evaluation for patients who remain at risk for failure, assessed up to 4 years

  7. Overall survival

    A Kaplan-Meier plot will be produced.

    Measured: From the day of first treatment to the earlier of death (from any cause) and the last date of patient contact, assessed up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2013 (estimated)
  2. Study start19 Apr 2013
  3. Primary completion13 Jul 2017
  4. Study completion28 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01770132
Sponsor's protocol ID
IUCRO-0319
Other IDs
1207009096
Status last verified
Dec 2018
First submitted
15 Jan 2013
Last updated
13 Dec 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30222972

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing porfimer sodium, endoscopic ultrasonography and photodynamic therapy in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by John DeWitt at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01770132, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.

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