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Alkylating agents

Chemotherapy Switch + Losartan for Pancreatic Cancer

Phase 2

Recruiting

Led By Charles D Lopez

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

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

Must have

No history of previous chemotherapy for pancreatic cancer

Hemoglobin > 9 g/dL with no blood transfusion within 28 days of starting treatment

Must not have

Evidence of metastasis to distant organs

Personal history of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether an early switch from one chemotherapy regimen to another, plus the drug losartan, is effective in treating patients with pancreatic cancer.

Who is the study for?

Adults with pancreatic cancer that is resectable, borderline resectable, or locally-advanced unresectable. They must have proper liver function, no history of other cancers with less than a 90% cure rate, not be pregnant or breastfeeding, and agree to use contraception. Participants should not have had previous chemotherapy for pancreatic cancer (except possibly one cycle), and must be physically fit enough for surgery.

What is being tested?

The trial tests if switching from mFOLFIRINOX to gemcitabine/nab-paclitaxel before surgery improves outcomes in patients with certain types of pancreatic cancer. It also examines the effects of adding losartan to these treatments. The study involves chemotherapy drugs designed to kill or stop the spread of tumor cells.

What are the potential side effects?

Chemotherapy may cause side effects like nausea, vomiting, hair loss, fatigue, increased risk of infection due to low blood cell counts, and potential allergic reactions. Losartan can lead to dizziness due to lowered blood pressure among other possible side effects.

Eligibility Criteria

Inclusion Criteria

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

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I have never had chemotherapy for pancreatic cancer.

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My hemoglobin is above 9 g/dL and I haven't had a blood transfusion in the last 28 days.

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My kidney function is normal or only slightly reduced.

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I am fully active or can carry out light work.

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My scans show no signs of cancer spread before joining the study or before receiving one standard treatment cycle.

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I am 18 years old or older.

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My diagnosis of pancreatic cancer is confirmed by lab tests.

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My pancreatic cancer is either operable, borderline operable, or advanced but not spread far.

Exclusion Criteria

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

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My cancer has spread to distant parts of my body.

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I have had fainting spells, irregular heartbeats, or sudden cardiac arrest due to heart issues.

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I have another cancer with less than a 90% chance of being cured.

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I have not had major surgery in the last 4 weeks.

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I am not using any other cancer treatments not allowed in this study.

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I have had only one round of chemotherapy or less for my pancreatic cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 24 months 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

DFSNeoOPTIMIZE + preop-RT

Disease-free survival (DFS) NeoOPTIMIZE

Incidence of grade >= 3 toxicities

+6 more

Other study objectives

CA19-9 serum levels (U/ml)

T-Lymphocyte Subsets

DFSNeoOPTMIZE for LAPC cohort

+7 more

Side effects data

From 2016 Phase 2 trial • 60 Patients • NCT00096226

93%

Fatigue

81%

Dyspnea

72%

Cough

67%

Hemoglobin

65%

Leukopenia NOS

61%

Nausea

60%

Anorexia

60%

Hyperglycemia NOS

58%

Dysphagia

56%

Esophagitis NOS

53%

Dermatitis radiation NOS

49%

Peripheral sensory neuropathy

46%

Weight decreased

44%

Constipation

44%

Alopecia

39%

Neutrophil count

35%

Pneumonitis NOS

33%

Chest pain

32%

Skin hyperpigmentation

30%

Platelet count decreased

30%

Chest wall pain

28%

Hypoalbuminemia

26%

Hyponatremia

25%

Lymphopenia

25%

Diarrhea NOS

25%

Pleural effusion

23%

Dyspepsia

23%

Vomiting NOS

21%

Aspartate aminotransferase increased

21%

Arthralgia

21%

Insomnia

19%

Sinus tachycardia

19%

Pain - Other

19%

Alanine aminotransferase increased

19%

Dehydration

19%

Hypocalcemia

19%

Myalgia

18%

Esophageal pain

18%

Pericardial effusion

18%

Supraventricular arrhythmia NOS

18%

Pyrexia

18%

Hypokalemia

18%

Atelectasis

18%

Pneumothorax NOS

16%

Blood alkaline phosphatase increased

16%

Hyperkalemia

16%

Dysgeusia

14%

Hypomagnesemia

14%

Back pain

14%

Headache

14%

Dizziness

14%

Pharyngolaryngeal pain

14%

Pruritus

12%

Blood/bone marrow - Other

12%

Pulmonary fibrosis

12%

Dry skin

12%

Sweating increased

12%

Hypersensitivity NOS

11%

Radiation recall syndrome

11%

Metabolic/laboratory - Other

11%

Pain in extremity

11%

Depression

11%

Hypoxia

11%

Laryngitis NOS

11%

Dermatitis exfoliative NOS

11%

Hypotension NOS

Dry mouth

Stomatitis

Blood bilirubin increased

Blood creatinine increased

Anxiety

Thrombosis

Pulmonary/upper respiratory - Other

Dermatology/skin - Other

Edema: limb

Hypermagnesemia

Bone pain

Pollakiuria

Bronchospasm

Hot flushes NOS

Rigors

Gastritis NOS

Vision blurred

Mucositis/stomatitis (functional/symptomatic): Esophagus

Blood bicarbonate decreased

Hypercalcemia

Hypophosphatemia

Muscle weakness NOS

Peripheral motor neuropathy

Ataxia

Confusional state

Epistaxis

Rhinitis allergic NOS

Prolonged chest tube drainage or air leak after pulmonary resection

Arrhythmia NOS

Myocardial ischemia

Abdominal distention

Colonic obstruction

Ocular/visual - Other

Ileus paralytic

Serum sickness

Infection with normal ANC or Grade 1 or 2 neutrophils: Wound

Anal infection NOS

Gingival infection

Urinary retention

Acute respiratory distress syndrome

Erythema multiforme

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Chemoradiation, Surgery, Chemotherapy

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (mFOLFIRINOX, chemotherapy)Experimental Treatment10 Interventions

mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycles. Those with response and no disease progression may receive an additional 2 months. GA REGIMEN: Those with disease progression or toxicity to mFOLFIRINOX switch to GA regimen comprising gemcitabine hydrochloride IV over 30-60 mins and nab-paclitaxel IV over 30-40 mins on days 1, 8, and 15. Repeats every 28 days for 2 cycles. LOSARTAN: Cycle 1 day 1, start losartan potassium orally once daily until end of RT. RT/SURGERY: Short-course RT for 10 fractions over 5 days weekly or long-course RT with 15-25 fractions over 5 days weekly along with oral capecitabine twice daily on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks following RT

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~4280

Radiation Therapy

2017

Completed Phase 3

~7250