← Back to Search

Anti-metabolites

Chemotherapy + Radiation for Pancreatic Cancer

Phase 2
Recruiting
Led By Naveenraj Solomon, MD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cytologic or histologic proof of adenocarcinoma of the pancreas
Adequate hematologic, renal and hepatic function as defined by: ANC greater or equal to 1,500 cells/mm3, Platelets greater or equal to 100,000 cells/mm3, Serum bilirubin ≤ 1.5 x upper limit of normal (ULN), Serum creatinine ≤ 2 x ULN, ALT ≤ 5 x ULN, AST ≤ 5 x ULN
Must not have
Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Patient has borderline resectable or metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every six months up to 6 years post-resection.
Awards & highlights

Summary

This trial is testing whether adding chemotherapy and radiation to the standard of care for resectable pancreatic cancer can improve the chances of surgeons achieving an R0 resection.

Who is the study for?
This trial is for adults over 18 with confirmed pancreatic adenocarcinoma that hasn't been treated yet. They must have good blood, kidney, and liver function, no serious infections needing IV antibiotics, and tumors that can potentially be removed by surgery. Pregnant or breastfeeding individuals or those with recent other cancers are excluded.
What is being tested?
The study tests if giving two FDA-approved chemotherapy drugs (gemcitabine and nab-paclitaxel) plus radiation therapy before surgery can improve the chances of completely removing pancreatic cancer. The main goal is to see if this approach leads to a high rate of complete tumor removal without any remaining cancer cells.
What are the potential side effects?
Possible side effects include reactions from the chemotherapy like nausea, fatigue, hair loss, low blood cell counts leading to increased infection risk or bleeding problems; as well as skin irritation or other issues related to radiation therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My diagnosis is pancreatic adenocarcinoma.
Select...
My blood, kidney, and liver tests are within the required ranges.
Select...
I am 18 years old or older.
Select...
I haven't needed IV antibiotics for an infection when starting this study.
Select...
I have never been treated for pancreatic cancer before.
Select...
My tumor can possibly be removed with surgery.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any serious infections that need treatment with medication.
Select...
My cancer is at a stage where surgery might not remove it all, or it has spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every six months up to 6 years post-resection.
This trial's timeline: 3 weeks for screening, Varies for treatment, and every six months up to 6 years post-resection. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Curative Intent Resection (R0) rate
Secondary study objectives
Disease Free Survival Rate
Overall Survival Rate

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
87%
Fatigue
53%
Nausea
33%
Cough
27%
Dyspnea
27%
Depression
27%
Platelet count decreased
27%
Anemia
27%
Pain
27%
Fall
27%
Lymphocyte count decreased
20%
Chills
20%
Edema limbs
20%
Neutropenia
20%
Diarrhea
20%
Dizziness
20%
Chest pain
13%
Dysesthesia
13%
Edema
13%
Vomiting
13%
Tinnitus
13%
Skin infection
13%
Myalgia
13%
Rash
13%
Back pain
13%
Insomnia
13%
Constipation
13%
Delirium
13%
Dysgeusia
13%
Weakness (limb)
13%
Weight loss
7%
Hypoxic respiratory failure
7%
Hypernatremia
7%
Seizures
7%
Headaches
7%
Death NOS
7%
Encephalopathy
7%
Gait disturbance
7%
Fever
7%
Sneezing
7%
Tremor
7%
Amnesia
7%
Oral lesions
7%
Neutrophil count decreased
7%
Photophobia
7%
Pleural effusion
7%
Proteinuria
7%
Urinary frequency
7%
Cognitive disturbance
7%
Muscle weakness
7%
Lung infection
7%
Acute kidney injury
7%
Hypertension
7%
Allergy (seasonal)
7%
Dysphagia
7%
Bruising
7%
Low white blood count
7%
Hypomagnesemia
7%
Nasal congestion
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Anxiety
7%
Anorexia
7%
Creatinine increased
7%
Hypokalemia
7%
Erythema multitforme
7%
Headache
7%
Hearing impaired
7%
Hearing loss
7%
Lymphocytopenia
7%
Sleep apnea
7%
Urinary urgency
7%
Weakness (facial)
7%
Hypoxia
7%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Chemotherapy and SBRTExperimental Treatment3 Interventions
Pre-Operative Chemotherapy: Within 28 days of study enrollment, subjects will receive a combination of Gemcitabine and Nab-paclitaxel for a maximum of four 28-day cycles. Gemcitabine 1000 mg/m2 IV on Days 1,8,15. Nab-paclitaxel 125 mg/m2 on Days 1,8,15. Post-Operative Chemotherapy: Within 5-10 weeks after surgery, subjects will receive a combination of Gemcitabine and Nab-paclitaxel for a maximum of two 28-day cycles. Gemcitabine 1000 mg/m2 IV on Days 1,8,15. Nab-paclitaxel 125 mg/m2 on Days 1,8,15. Standard Stereotactic Body Radiation Therapy (SBRT) fractionation of 6 Gy per day will be used for all patients to a total dose of 30 Gy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
nab-paclitaxel
2008
Completed Phase 4
~1430
Gemcitabine 1000 mg
2017
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
312 Previous Clinical Trials
260,875 Total Patients Enrolled
Naveenraj Solomon, MDPrincipal InvestigatorLoma Linda University Cancer Center

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03492671 — Phase 2
Pancreatic Adenocarcinoma Research Study Groups: Chemotherapy and SBRT
Pancreatic Adenocarcinoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT03492671 — Phase 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03492671 — Phase 2
~0 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top