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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 below

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My diagnosis is pancreatic adenocarcinoma.

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My blood, kidney, and liver tests are within the required ranges.

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I am 18 years old or older.

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I haven't needed IV antibiotics for an infection when starting this study.

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I have never been treated for pancreatic cancer before.

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My tumor can possibly be removed with surgery.

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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:

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I do not have any serious infections that need treatment with medication.

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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.

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%

Pain

27%

Fall

27%

Dyspnea

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

27%

Anemia

20%

Dizziness

20%

Chills

20%

Edema limbs

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

13%

Dysesthesia

13%

Edema

13%

Insomnia

13%

Constipation

13%

Delirium

13%

Dysgeusia

13%

Myalgia

13%

Skin infection

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Bruising

Hearing loss

Anxiety

Headaches

Oral lesions

Weakness (facial)

Neutrophil count decreased

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Hearing impaired

Hypernatremia

Creatinine increased

Headache

Death NOS

Gait disturbance

Nasal congestion

Fever

Tremor

Urinary urgency

Hypoxic respiratory failure

Amnesia

Photophobia

Pleural effusion

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Erythema multitforme

Lung infection

Hypertension

Allergy (seasonal)

Muscle weakness

Proteinuria

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

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