← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 24 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have never had chemotherapy for pancreatic cancer.
Select...
My hemoglobin is above 9 g/dL and I haven't had a blood transfusion in the last 28 days.
Select...
I haven't had a laparoscopy to diagnose my condition.
Select...
My kidney function is normal or only slightly reduced.
Select...
My bilirubin levels are within the normal range or improving after a biliary procedure.
Select...
I am considered fit for surgery aimed at curing my condition.
Select...
I am fully active or can carry out light work.
Select...
I have taken a pregnancy test in the last 72 hours and it was negative.
Select...
My scans show no signs of cancer spread before joining the study or before receiving one standard treatment cycle.
Select...
I am 18 years old or older.
Select...
I agree to use birth control if I can have children.
Select...
My diagnosis of pancreatic cancer is confirmed by lab tests.
Select...
I agree to use effective birth control during the study.
Select...
My pancreatic cancer is either operable, borderline operable, or advanced but not spread far.
Select...
I am currently taking ACE inhibitors or ARB medications.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with R0 resection
Secondary outcome measures
DFSNeoOPTIMIZE + preop-RT
Disease-free survival (DFS) NeoOPTIMIZE
Incidence of grade >= 3 toxicities
+6 more
Other outcome measures
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%
Pleural effusion
25%
Diarrhea NOS
25%
Lymphopenia
23%
Dyspepsia
23%
Vomiting NOS
21%
Aspartate aminotransferase increased
21%
Arthralgia
21%
Insomnia
19%
Sinus tachycardia
19%
Alanine aminotransferase increased
19%
Dehydration
19%
Hypocalcemia
19%
Myalgia
19%
Pain - Other
18%
Atelectasis
18%
Pneumothorax NOS
18%
Pericardial effusion
18%
Supraventricular arrhythmia NOS
18%
Hypokalemia
18%
Pyrexia
18%
Esophageal pain
16%
Blood alkaline phosphatase increased
16%
Hyperkalemia
16%
Dysgeusia
14%
Pharyngolaryngeal pain
14%
Hypomagnesemia
14%
Back pain
14%
Dizziness
14%
Headache
14%
Pruritus
12%
Pulmonary fibrosis
12%
Blood/bone marrow - Other
12%
Dry skin
12%
Sweating increased
12%
Hypersensitivity NOS
11%
Laryngitis NOS
11%
Hypoxia
11%
Radiation recall syndrome
11%
Metabolic/laboratory - Other
11%
Pain in extremity
11%
Dermatitis exfoliative NOS
11%
Depression
11%
Hypotension NOS
9%
Pulmonary/upper respiratory - Other
9%
Blood bilirubin increased
9%
Dry mouth
9%
Stomatitis
9%
Blood creatinine increased
9%
Anxiety
9%
Dermatology/skin - Other
9%
Thrombosis
7%
Hot flushes NOS
7%
Bronchospasm
7%
Edema: limb
7%
Hypermagnesemia
7%
Bone pain
7%
Pollakiuria
7%
Rigors
5%
Rhinitis allergic NOS
5%
Epistaxis
5%
Prolonged chest tube drainage or air leak after pulmonary resection
5%
Vision blurred
5%
Gastritis NOS
5%
Mucositis/stomatitis (functional/symptomatic): Esophagus
5%
Blood bicarbonate decreased
5%
Hypercalcemia
5%
Hypophosphatemia
5%
Ataxia
5%
Muscle weakness NOS
5%
Peripheral motor neuropathy
5%
Confusional state
2%
Colonic obstruction
2%
Arrhythmia NOS
2%
Ocular/visual - Other
2%
Ileus paralytic
2%
Abdominal distention
2%
Myocardial ischemia
2%
Serum sickness
2%
Anal infection NOS
2%
Gingival infection
2%
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
2%
Erythema multiforme
2%
Syncope
2%
Urinary retention
2%
Acute respiratory distress syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemoradiation, Surgery, Chemotherapy

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
Oxaliplatin
2011
Completed Phase 4
~2560
Capecitabine
2013
Completed Phase 3
~3420
Fluorouracil
2014
Completed Phase 3
~11540
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Leucovorin Calcium
2011
Completed Phase 3
~12290
Losartan Potassium
2007
Completed Phase 4
~1060
Radiation Therapy
2017
Completed Phase 3
~7250
Resection
2021
Completed Phase 2
~410
Biospecimen Collection
2004
Completed Phase 2
~1920

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
226 Previous Clinical Trials
2,090,443 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
967 Previous Clinical Trials
6,845,626 Total Patients Enrolled
Charles D Lopez5.01 ReviewsPrincipal Investigator - OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
2 Previous Clinical Trials
95 Total Patients Enrolled

Media Library

Fluorouracil (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04539808 — Phase 2
Pancreatic Adenocarcinoma Research Study Groups: Treatment (mFOLFIRINOX, chemotherapy)
Pancreatic Adenocarcinoma Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT04539808 — Phase 2
Fluorouracil (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04539808 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are associated with Resection?

"Although Phase 2 trials have not yet yielded data on efficacy, there is some evidence supporting Resection's safety. Therefore, it received a score of 2."

Answered by AI

How many individuals are enrolled in this clinical trial?

"That is correct. The clinicaltrials.gov website indicates that this study has an active recruitment status. This trial was originally posted on May 27th, 2021 and updated on August 25th, 2022. They are looking to enroll 60 patients at a single site."

Answered by AI

What are the other medical procedures that commonly use Resection?

"Currently, there are 924 Resection trials underway. 277 of those studies are in their final Phase 3 stage. The majority of the research is based in Guangzhou, Guangdong; however, there are 34568 locations conducting these investigations."

Answered by AI

What kind of medical conditions does Resection commonly target?

"Patients with kidney failure, refractory fallopian tube carcinoma, and small cell lung cancer (sclc) can explore Resection as a possible treatment option."

Answered by AI

Are there any vacancies in this research project for new participants?

"From what is detailed on clinicaltrials.gov, this research project is currently seeking volunteers. This trial was originally posted on May 27th, 2021 and was most recently updated on August 25th, 2022."

Answered by AI
~0 spots leftby Apr 2024