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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
No Placebo-Only Group
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ every six months up to 6 years post-resection.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every six months up to 6 years post-resection.
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 • NCT0204544687%
Fatigue
53%
Nausea
33%
Cough
27%
Pain
27%
Fall
27%
Dyspnea
27%
Depression
27%
Lymphocyte count decreased
27%
Platelet count decreased
27%
Anemia
20%
Chills
20%
Dizziness
20%
Edema limbs
20%
Chest pain
20%
Neutropenia
20%
Diarrhea
13%
Edema
13%
Dysesthesia
13%
Dysgeusia
13%
Insomnia
13%
Constipation
13%
Delirium
13%
Skin infection
13%
Vomiting
13%
Tinnitus
13%
Myalgia
13%
Rash
13%
Back pain
13%
Weakness (limb)
13%
Weight loss
7%
Proteinuria
7%
Bruising
7%
Hearing loss
7%
Anxiety
7%
Headaches
7%
Acute kidney injury
7%
Hypokalemia
7%
Oral lesions
7%
Lymphocytopenia
7%
Neutrophil count decreased
7%
Weakness (facial)
7%
Seizures
7%
Hearing impaired
7%
Hypernatremia
7%
Creatinine increased
7%
Headache
7%
Death NOS
7%
Gait disturbance
7%
Nasal congestion
7%
Fever
7%
Tremor
7%
Urinary urgency
7%
Hypoxic respiratory failure
7%
Amnesia
7%
Photophobia
7%
Pleural effusion
7%
Urinary frequency
7%
Dysphagia
7%
Low white blood count
7%
Sneezing
7%
Cognitive disturbance
7%
Muscle weakness
7%
Erythema multitforme
7%
Lung infection
7%
Hypertension
7%
Allergy (seasonal)
7%
Hypomagnesemia
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Anorexia
7%
Sleep apnea
7%
Encephalopathy
7%
Hypoxia
7%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy
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: 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
~1420
Gemcitabine 1000 mg
2017
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
314 Previous Clinical Trials
266,460 Total Patients Enrolled
Naveenraj Solomon, MDPrincipal InvestigatorLoma Linda University Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer except for minor skin cancers or cancers cured by surgery or surgery plus radiotherapy in the last 5 years.My diagnosis is pancreatic adenocarcinoma.My blood, kidney, and liver tests are within the required ranges.I do not have any serious infections that need treatment with medication.I am 18 years old or older.My cancer is at a stage where surgery might not remove it all, or it has spread.I haven't needed IV antibiotics for an infection when starting this study.I have never been treated for pancreatic cancer before.My tumor can possibly be removed with surgery.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Chemotherapy and SBRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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