Losartan and Hypofractionated Rx After Chemo for Tx of Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer (SHAPER) (SHAPER)

  • STATUS
    Recruiting
  • End date
    Aug 8, 2025
  • participants needed
    20
  • sponsor
    University of Utah
Updated on 13 May 2022

Summary

This phase I trial studies the side effects of losartan and hypofractionated radiation therapy after chemotherapy in treating patients with pancreatic cancer that may or may not be removed by surgery (borderline resectable) or has spread from its original site of growth to nearby tissues or lymph nodes and is not amenable to surgical resection (locally advanced unresectable). Losartan may improve blood flow and allows for better tissue oxygenation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving losartan and hypofractionated radiation therapy may work better in treating patients with pancreatic cancer compared to hypofractionated radiation therapy alone.

Description

PRIMARY OBJECTIVE:

I. To assess the safety of losartan potassium (losartan) in combination with hypofractionated radiation treatment for patients with stable or locally progressive pancreatic ductal adenocarcinoma (PDAC) after induction chemotherapy.

SECONDARY OBJECTIVES:

I. To assess the safety of losartan in combination with HRT for patients with stable or locally progressive PDAC after induction chemotherapy.

II. To assess the efficacy of losartan in combination with HRT for patients with stable or locally progressive PDAC after induction chemotherapy.

III. To assess the rate of hypotensive adverse events grade >= 3.

EXPLORATORY OBJECTIVE:

I. To assess patient reported quality of life.

OUTLINE

Beginning day 1, patients receive losartan potassium orally (PO) once daily (QD). Beginning day 14, patients also undergo hypofractionated radiation therapy over 15 fractions 5 days a week for up to 3 weeks. Patients continue to receive losartan potassium PO QD during radiation therapy and for 28 days after completion of radiation therapy.

After completion of study treatment, patients are followed up at 28 and 84 days, every 3 months for 12 months, and then every 6 months for up to 36 months.

Details
Condition Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma, Locally Advanced Unresectable Pancreatic Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8, Stage IIA Pancreatic Cancer AJCC v8, Stage IIB Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8
Treatment questionnaire administration, quality-of-life assessment, hypofractionated radiation therapy, losartan, Losartan Potassium
Clinical Study IdentifierNCT04106856
SponsorUniversity of Utah
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed pancreatic ductal adenocarcinoma
Borderline resectable or locally advanced unresectable pancreas cancer as defined by the National Comprehensive Cancer Network (NCCN) and determined by a pancreatic surgeon prior to therapy. This can be confirmed by the surgeon?s documentation in the electronic medical record, by a treatment planning conference note, or by the signature of a pancreatic surgeon
At least one infusion of FOLFIRINOX or gemcitabine based chemotherapy must have been attempted
Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
No more than 6 months of chemotherapy. Each completed cycle of FOLFIRINOX will be counted as 0.5 months. Each completed cycle of gemcitabine based chemotherapy will be counted as 1 month. If a partial cycle of chemotherapy is given, that partial cycle will be counted proportional to the amount given. E.G. if one of three planned infusions of gemcitabine based chemotherapy is given, it will be counted as 1/3 month
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Enrollment must occur within 90 days of Day 1 of the last infusion given of chemotherapy. Patients who have primary tumor or regional lymph node progression on chemotherapy or prior to enrollment are eligible if no distant metastases are identified on the screening imaging assessment
Absolute neutrophil count (ANC) >= 1500/uL
Platelets >= 100k/uL
Total Bilirubin =< 2.0 mg/dL
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN)
Serum creatinine < 1.25 md/dL
Serum potassium < 5.0 mmol/L
Negative serum or urine pregnancy test at screening for women of childbearing potential
Highly effective contraception for both male and female subjects throughout the study and for at least 12 months after last study treatment administration if the risk of conception exists
Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from toxicities related to any prior treatments, unless AEs are clinically nonsignificant and/or stable on supportive therapy
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria

Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen of this trial
Distant metastases. Regional lymphatic disease is acceptable
Prior radiation therapy or definitive resection for pancreatic cancer
Uncontrolled gastric or duodenal ulcer disease within 28 days of registration
Chronic cough, defined 30% of days over 3 months with active symptoms at enrollment or over 12 months with last active symptoms occurring 6 months prior to enrollment
Symptomatic hypotension (blood pressure < 90 systolic or < 60 diastolic at screening vital sign assessment) that has the potential to interfere with the patient's safety or ability to complete protocol treatment, at the discretion of the treating investigator
Patients taking > 50mg losartan QD who, at the discretion of the treating investigator, cannot be reduced to the protocol defined regimen
Patients taking an angiotensin II receptor blocker or an angiotensin-converting enzyme inhibitor who, at the discretion of the treating investigator, cannot be safely discontinued prior to Day 1 dosing
Patients taking direct renin-angiotensin system inhibitors including aliskiren (Rasilez)
Prior allergy to an angiotensin II receptor blocker
Concurrent use of direct renin inhibitor including aliskiren (Rasilez)
Patients with known history of
Heart failure. Patients with heart failure, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
Patients with a prior history of treatment with cardiotoxic agents should be evaluated for heart failure prior to enrollment at the discretion of the treating investigator
Solitary kidney, renal artery stenosis, or chronic renal failure
Patients with known evidence of chronic hepatitis B virus (HBV) infection and a detectable HBV viral load
Patients with a history of hepatitis C virus (HCV) infection who have not been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Human immunodeficiency virus (HIV)-infected patients who are not on effective
Subject is currently enrolled on another investigational treatment study for pancreas cancer
anti-retroviral therapy or have a detectable viral load within 6 months of
trial entry
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note