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Acinar Cell Adenocarcinoma of the PancreasEarly Phase 1NCT02153450

Stereotactic Radiosurgery and Metformin in Patients With Borderline-Resectable or Locally-Advanced Pancreatic Cancer

A Early Phase 1 study testing metformin hydrochloride and stereotactic radiosurgery in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by Case Comprehensive Cancer Center 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 pilot clinical trial studies stereotactic radiosurgery and metformin hydrochloride in treating patients with pancreatic cancer that may be removed (borderline-resectable) or not removed by surgery. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
metformin hydrochloride and stereotactic radiosurgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
8 May 2015to 13 Jun 2020
Phase
Early 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must be able to provide written informed consent
  • Histologically and/or cytologically confirmed adenocarcinoma of the pancreas, clinical stage T1-4, N0-1, M0
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Hemoglobin ≥ 9.0 g/dl
  • Alkaline phosphatase < 3 x upper limit of normal (ULN)
  • Albumin > 2.5 g/dL
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  • Absolute neutrophil count ≥ 1500/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Total bilirubin < 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ 2.5 x institutional upper limit of normal
  • Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional upper limit of normal
  • Creatinine ≤ 1.5
  • Borderline-resectable or locally-advanced pancreatic cancer (based upon impression of the surgical oncologist, in conjunction with radiologic consultations) as defined per the Alliance consensus :
  • Borderline-resectable
  • An interface between the primary tumor and superior mesenteric vein (SMV)/portal vein measuring 180 degrees or greater of the circumference of the vein wall
  • Short-segment occlusion of the SMV/portal vein but with suitable vessel proximal and distal to the obstruction to allow safe resection and reconstruction
  • Short-segment interface (of any degree) between the tumor and the hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and arterial reconstruction
  • An interface between the tumor and the SMA or celiac trunk measuring less than 180 degrees of the circumference of the artery wall
  • Not surgically resectable due to one or more of the following things
  • Patient is not a surgical candidate due to medical comorbidities and/or poor performance status
  • Patient elects not to undergo surgical therapy
  • Patient has locally-advanced pancreatic cancer based on having one of the following:
  • Encasement of the SMA/celiac artery (>180 degrees).
  • Involvement of the SMV/portal vein without options for reconstruction.
  • Aortic invasion or encasement.
  • Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 6 weeks prior to study entry, for the duration of study participation and for 6 months after completing treatment; should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately
  • Patients previously treated with chemotherapy are eligible unless they have evidence of local or distant disease progression; patients must have completed their last cycle of chemotherapy at least two weeks prior to study enrollment
  • Patients currently taking metformin are eligible for participation.
  • Women of child-bearing potential and male patients who are sexually-active must agree to use effective methods of birth control throughout protocol treatment.
  • Patients must not have poorly-controlled diarrhea (no more than 4 loose stools per day). Patients may be reconsidered for the study if the diarrhea resolves.

Who cannot join

  • Evidence of gross duodenal invasion, gastric outlet obstruction
  • Gastrointestinal perforation or intra-abdominal abscess (< 3 months); recent (< 3 months) gastrointestinal (GI) bleeding from gastric or duodenal ulcer
  • Systemic collagen vascular disease including scleroderma or systemic lupus erythematosus (SLE); rheumatoid arthritis is eligible
  • Serious active infection requiring intravenous (IV) antibiotics
  • Conditions leading to inadequate gastrointestinal tract absorption as determined by the treating physician and/or investigator
  • Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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  • Poorly-controlled diarrhea (> 4 loose bowel movement [BM]/day without use of anti-motility agents) within 7 days of study enrollment; patients may be reconsidered for the study if the diarrhea resolves
  • Comorbid conditions that, in the opinion of the investigator, would complicate safety or compliance such as known human immunodeficiency virus (HIV) or current substance abuse
  • Patients who are pregnant or lactating
  • Patients who are unwilling or unable to comply with study and/or follow-up procedures
  • Treatment for other carcinomas within the last two years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer with stable prostate-specific antigen (PSA)
  • Multi-focal pancreatic lesions concerning for cancer.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

Other trials in United States

About this study

Official title: A Pilot Trial of Stereotactic Body Radiation Therapy and Metformin for Borderline-Resectable and Locally-Advanced Pancreatic Adenocarcinomas

This pilot clinical trial studies stereotactic radiosurgery and metformin hydrochloride in treating patients with pancreatic cancer that may be removed (borderline-resectable) or not removed by surgery. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Metformin hydrochloride, used for diabetes, may also kill cancer cells as demonstrated in laboratory studies. Giving stereotactic radiosurgery with metformin hydrochloride may kill more tumor cells.

Read the detailed description

This is an open label pilot, single-center, non-randomized trial is designed to evaluate the tolerability and preliminary activity of the combination of stereotactic body radiation therapy (SBRT) with metformin for resectable and locally-advanced pancreatic/periampullary cancers.

PRIMARY OBJECTIVES:

The primary objectives of this study are to:

  1. To determine if the addition of metformin to SBRT adds minimal additional toxicity for patients with A). borderline-resectable or B). not surgically resectable pancreatic adenocarcinomas.

SECONDARY OBJECTIVES:

  1. Evaluate the clinical/pathological response and resectability rates associated with these regimens.

OUTLINE:

Patients receive metformin hydrochloride orally (PO) daily or twice daily (BID) on days -11 to -1. Patients then undergo stereotactic radiosurgery 5 days a week for 5 weeks and receive concurrent metformin hydrochloride* by mouth, two times a day for 5 weeks. Patients undergo laparotomy on week 6 (or weeks 5-7). ). Systemic therapy continues as soon as it is considered feasible by the treating physicians.

*NOTE: Metformin hydrochloride should be stopped 2 days before laparotomy.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Being tested
metformin hydrochloride, stereotactic radiosurgery
Keywords
pancreatic cancer, Radiation, Metformin, Pancreatic Adenocarcinomas
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • metformin hydrochlorideDrug

    Also called Glucophage

    Given PO

  • stereotactic radiosurgeryRadiation

    Undergo stereotactic radiosurgery

Study groups in NCT02153450
Study groupRoleWhat they receive
Treatment (stereotactic radiosurgery, metformin hydrochloride)ExperimentalPatients receive metformin hydrochloride PO daily or BID on days -11 to -1. Patients then undergo stereotactic radiosurgery 5 days a week for 5 weeks and receive concurrent metformin hydrochloride* PO BID for 5 weeks. Patients undergo laparotomy on week 6 (or weeks 5-7). Systemic therapy continues as soon as it is considered feasible by the treating physicians. *NOTE: Metformin hydrochloride should be stopped 2 days before laparotomy.
Receives: Drug: metformin hydrochloride; Radiation: stereotactic radiosurgery

What is being measured

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

  1. Dose-limiting toxicity (DLT) rate scored according to the National Cancer Institute Common Toxicity Criteria version 4

    The rate of DLT for each treatment group will be estimated based on the number of incidences using a binomial distribution and its confidence intervals will be estimated using Wilson's method. The factors associated with DLT will be identified using logistic regression using forward model selection procedure

    Measured: Up to 21 days post-treatment

Secondary outcomes (3)

  1. Clinical response rate using the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Using a binomial distribution and its confidence intervals will be estimated using Wilson's method.

    Measured: Up to 2 years

  2. Progression-free survival using the revised RECIST version 1.1

    The factors associated with progression-free survival will be identified using logistic regression using forward model selection procedure.

    Measured: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years

  3. Overall survival

    The probability of overall survival along with median survival for each treatment group will be estimated using Kaplan-Meier method.

    Measured: Up to 2 years

Timeline

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

  1. First posted3 Jun 2014 (estimated)
  2. Study start8 May 2015
  3. Primary completion3 Aug 2018
  4. Study completion13 Jun 2020

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02153450
Sponsor's protocol ID
CASE4213
Other IDs
NCI-2014-01172, CASE 4213, P30CA043703
Status last verified
Jun 2020
First submitted
30 May 2014
Last updated
26 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing metformin hydrochloride and stereotactic radiosurgery in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by Case Comprehensive Cancer Center 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 30 inclusion and 12 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 26 Jun 2020. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Dose-limiting toxicity (DLT) rate scored according to the National Cancer Institute Common Toxicity Criteria version 4 (time frame: Up to 21 days post-treatment). 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 NCT02153450.

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 26 Jun 2020.

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