Recruiting
Phase 2

Gemcitabine & Nab-Paclitaxel

Sponsor:

Loma Linda University

Code:

NCT03492671

Conditions

Pancreas Adenocarcinoma

Resectable Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gemcitabine 1000 mg

nab-paclitaxel

Stereotactic Body Radiation Therapy

Study Details

Brief summary:

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.

Conditions

Pancreas Adenocarcinoma

Resectable Pancreatic Cancer

Study ID

NCT03492671

Start date

Jul 17, 2019

Status verified date

Sep, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria (all criteria must apply):

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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)

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)

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 measure

  • Curative Intent Resection (R0) rate [ Time Frame: Within 2 weeks prior to initiation of post-operative chemotherapy. ]

Central Contacts and Locations

Central contacts

Naveenraj Solomon, MD

909-558-5498nsolomon@llu.edu

Shagufta Shaheen, MD

909-558-4050sshaheen@llu.edu

Locations

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92354

Contacts

Naveenraj Solomon, MD

nsolomon@llu.edu

More Information

Sponsor

Loma Linda University

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Keywords

  • Pancreatic Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2025-10-02.