Testing The Combination Of Two Approved Chemotherapy Drugs And Radiation Prior To Surgery In Localized Pancreatic Cancer

Study Overview

Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer

The purpose of this phase 2 research study is to determine whether a combination of chemotherapy drugs plus radiation therapy, given before surgery in resectable pancreactic cancer, can help to increase the chances of surgeons achieving and R0 resection. The chemotherapy drugs used are gemcitabine and nab-paclitaxel. These drugs are both approved by the FDA for use in treating adults with pancreatic adenocarcinoma. The investigational portion of this study is providing the chemotherapy drugs and radiation therapy before surgery. Primary Endpoint, R) resection rate ≥70%. Secondary Endpoints, Disease free survival, Overall survival , Perioperative mortality and morbidity.

Primary Endpoint: R0 resection rate ≥ 70% Secondary Endpoints: Disease free survival, Overall survival, Perioperative mortality and morbidity Treatment should start within 28 days of registration. Pre-operative Chemotherapy Patients will receive a combination of the agents (gemcitabine and nab-paclitaxel) prior to surgery for a maximum of four cycles. Gemcitabine 1000 mg-m2 IV on days 1, 8, 15 Nab-paclitaxel 125 mg-m2 IV on days 1, 8, 15 28 day cycles Post-operative Chemotherapy Treatment should start within 5-10 weeks of surgery. Patients will receive a combination of the agents (gemcitabine and nab-paclitaxel) after surgery for maximum of two cycles. Gemcitabine 1000 mg-m2 IV on days 1, 8, 15 Nab-paclitaxel 125 mg-m2 IV on days 1, 8, 15 28 day cycles Radiation Therapy Immobilization and Treatment Planning CT Scan All patients will be immobilized in a full body immobilization device in the supine position. A 4D-CT scan from T5 to L5-S1 with intravenous and oral contrast will be performed. Radiation Toxicity All acute toxicities will be scored according to the NCI Common Toxicity Criteria v4.0. Late toxicity will be scored per RTOG guidelines. Surgery, Pre-operative Re-staging Pre-operative evaluation should occur within 2-4 weeks prior to the planned surgery date. Based on the results of the pre-operative evaluation, the corresponding action below should be taken. Radiological responding or stable disease: Patients should proceed to surgery per protocol. Surgery Pancreatic resection should occur within 4-10 weeks after the last dose of preoperative chemotherapy or SBRT. Staging laparoscopy may be performed at the time of planned laparotomy but is not required. Post-operative Restaging Evaluation should occur within 2 weeks prior to initiation of postoperative chemotherapy. Tumor Response Evaluation (Adapted From RECIST 1.1) Assessment of overall tumor burden and measurable disease To assess objective response or future progression, it is necessary to estimate the overall tumor burden at baseline and use this as a comparator for subsequent measurements. Only patients with measurable disease at baseline should be included in protocols where objective tumor response is the primary endpoint. Measurable disease is defined by the presence of at least one measurable. In studies where the primary endpoint is tumor progression (either time to progression or proportion with progression at a fixed date), the protocol must specify if entry is restricted to those with measurable disease or whether patients having non-measurable disease only are also eligible.

Pancreas Adenocarcinoma
Resectable Pancreatic Cancer

DRUG: Gemcitabine 1000 mg
DRUG: nab-paclitaxel
RADIATION: Stereotactic Body Radiation Therapy

5170277

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-04-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-09-30
First Submitted that Met QC Criteria 2018-04-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-10-02
First Posted (ACTUAL) 2018-04-10	Results First Posted N/A	Last Verified 2024-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Chemotherapy and SBRT 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.	DRUG: Gemcitabine 1000 mg Pre-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles) DRUG: nab-paclitaxel Pre-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles) RADIATION: Stereotactic Body Radiation Therapy 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Chemotherapy and SBRT

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.

DRUG: Gemcitabine 1000 mg

Pre-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles)

DRUG: nab-paclitaxel

Pre-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles)

RADIATION: Stereotactic Body Radiation Therapy

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.

Primary Outcome Measures	Measure Description	Time Frame
Curative Intent Resection (R0) rate	Measure the rate of R0 resection with all margins microscopically clear.	Within 2 weeks prior to initiation of post-operative chemotherapy.

Secondary Outcome Measures	Measure Description	Time Frame
Disease Free Survival Rate	Subject will be followed post-resection for evidence of pancreatic cancer.	Every three months up to two years after resection.
Overall Survival Rate	Subject will be followed post-resection for overall survival rate.	Every six months up to 6 years post-resection.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Naveenraj Solomon, MD

Phone Number: 909-558-5498

Email: nsolomon@llu.edu

Study Contact Backup

Name: Shagufta Shaheen, MD

Phone Number: 909-558-4050

Email: sshaheen@llu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Cytologic or histologic proof of adenocarcinoma of the pancreas.
Localized, potentially resectable tumors.
Greater or equal to 18 years of age.
ECOG performance status of 0 or 1.
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
No history of prior therapy for pancreatic cancer.
No history of active infection requiring IV antibiotics at the start of study treatment
Non-pregnant and non-breast-feeding.

Patient has borderline resectable or metastatic disease.
History of malignancy in the last 5 years other than in situ cancer or basal or squamous cell skin cancer or malignancies cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Naveenraj Solomon, MD, Loma Linda University Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record