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Chemotherapy

Combined Therapy for Pancreatic Cancer

Phase 2

Waitlist Available

Led By Theodore S. Hong, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Histologically confirmed localized pancreatic adenocarcinoma; borderline/potentially resectable or locally advanced

Must not have

History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-fluorouracil, irinotecan, oxaliplatin, or losartan

Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until the time of death, up to approximately 6 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing to see if the combination of these interventions can effectively treat pancreatic tumors.

Who is the study for?

This trial is for adults over 18 with localized pancreatic adenocarcinoma that's potentially resectable or advanced. Participants must have stable blood pressure, normal organ/marrow function, and an ECOG status of 0-1. Women should use contraception; those pregnant or breastfeeding are excluded. People can't join if they've had certain allergic reactions, severe infections like TB, HIV/AIDS, uncontrolled health issues, recent major surgery without recovery, prior treatments for their tumor or live vaccines within a month.

What is being tested?

The study tests a combination treatment for pancreatic cancer including FOLFIRINOX (a mix of four drugs), Losartan (a blood pressure medication), Nivolumab (an immunotherapy drug), radiation therapy and surgery to see how well they work together in treating the tumor.

What are the potential side effects?

Possible side effects include reactions to the chemotherapy drugs such as nausea, fatigue, low blood counts leading to increased infection risk; high blood pressure from Losartan; immune-related effects from Nivolumab like inflammation in organs; and typical risks associated with radiation therapy and surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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My pancreatic cancer is confirmed and may be operable or advanced but not spread.

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I have been on a stable dose of dexamethasone (2 mg or less) for at least 7 days.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to certain chemotherapy drugs or losartan.

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I had major surgery less than 4 weeks ago and haven't fully recovered.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have or had lung inflammation not caused by an infection.

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I have an active tuberculosis infection.

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I have received treatments like chemotherapy for my pancreatic tumor.

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I have issues with my digestive system that affect how I absorb food.

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I am not taking cimetidine, as it can affect my cancer treatment.

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I have a bleeding disorder that is not under control.

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I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.

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I have not received a live vaccine in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until the time of death, up to approximately 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until the time of death, up to approximately 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until the time of death, up to approximately 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with R0 resection

Secondary study objectives

Number of participants with treatment related serious adverse events

Overall survival

Pathologic complete response

+1 more

Side effects data

From 2023 Phase 2 trial • 19 Patients • NCT01595321

100%

Diarrhea

100%

Bone pain

100%

Fatigue

100%

Febrile neutropenia

100%

Lymphocyte count decreased

100%

Chills

67%

White blood

67%

Hypomagnesemia

67%

Alopecia

67%

Neutrophil count decreased

67%

Hypokalemia

67%

Weight loss

67%

Anorexia

67%

Vomiting

67%

Dry Skin

67%

Epistaxis

67%

Nausea

67%

Abdominal pain

67%

Flatulence

67%

Platelet count decreased

67%

Anemia

33%

Hypophosphatemia

33%

Agitation

33%

Skin tears

33%

Peripheral sensory neuropathy

33%

Atelectasis

33%

Concentration impairment

33%

Headache

33%

Decreased breath sounds

33%

Hoarseness

33%

Somnolence

33%

Pleural effusion

33%

Sepsis

33%

Sinus tachycardia

33%

Skin and Subcutaneous Tissue disorder

33%

Syncope

33%

Small intestinal obstruction, partial

33%

Sore throat

33%

Ascities

33%

Dehydration

33%

Dizziness

33%

Dysgeusia

33%

Fecal incontinence

33%

Fever

33%

Gastroesophageal reflux disease

33%

Gastrointestinal pain

33%

Hypoalbuminemia

33%

Peripheral motor neuropathy

33%

Bruising

33%

Fall

33%

Hearing imaired

33%

Hepatic infection

33%

Hypocalcemia

33%

Insomnia

33%

Lip infection

33%

Mucositis (oral ulcers)

33%

Wound dehiscence

33%

Lower gastrointestinal hemorrhage

33%

Pain

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: SBRT and FOLFIRINOX

Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX

Cohort 2: SBRT and Modified FOLFIRINOX

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: FOLFIRINOX+Losartan:SBRT+Nivolumab+Losartan:SurExperimental Treatment5 Interventions

The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion * Losartan will be administered orally as a tablet to be taken by the patient at home every day * SBRT should be administered 2-6 weeks after completing chemotherapy * Participants will receive nivolumab during SBRT * All participants will undergo an attempt at definitive surgical resection following SBRT

Group II: FOLFIRINOX+Losartan:SBRT+Losartan:SurgeryExperimental Treatment4 Interventions

The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion * Losartan will be administered orally as a tablet to be taken by the patient at home every day * SBRT should be administered 2-6 weeks after completing chemotherapy * All participants will undergo an attempt at definitive surgical resection following SBRT

Group III: FOLFIRINOX x 8 : SBRT + Nivolumab : SurgeryExperimental Treatment4 Interventions

* The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion * SBRT should be administered 2-6 weeks after completing chemotherapy * Participants will receive nivolumab during SBRT * All participants will undergo an attempt at definitive surgical resection following SBRT

Group IV: FOLFIRINOX: SBRT: SurgeryActive Control3 Interventions

The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion * SBRT should be administered 2-6 weeks after completing chemotherapy * All participants will undergo an attempt at definitive surgical resection following SBRT

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FOLFIRINOX

2013

Completed Phase 3

~800

Nivolumab

FDA approved

SBRT

2014