Phase II Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer

NCT02241551 | Terminated Phase 2 Results DMC

• 1 other identifier: UPCI 13-143
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized phase II trial. Patients diagnosed with borderline resectable pancreatic adenocarcinoma will be randomly assigned to one of two treatment arms, either mFOLFIRINOX or gemcitabine and nab-paclitaxel. After three cycles of treatment in the gemcitabine/nab-paclitaxel arm and 6 cycles in the mFOLFIRINOX arm, patients will be restaged with CT scans and if they remain borderline resectable or have improvement of their disease They will then proceed to SBRT followed by surgical resection.

Conditions

Borderline Resectable Pancreatic Cancer

Keywords

Borderline; Resectable; Pancreatic; Cancer; Neoadjuvant; Chemotheraphy; Gemcitabine; Nab-Paclitaxel; mFOFIRINOX; Sterotatic Body Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Safety and Efficacy Using Neo-adjuvant Gemcitabine Plus Nab-paclitaxel in Patients Receiving SBRT and Surgery for Borderline Resectable Pancreatic Cancer, Using Neo-adjuvant mFOLFIRINOX as a Control

  Efficacy: pathological complete response (pCR) and R0 resection. Safety: Grade 4 toxicity.

  up to 5 years

Secondary Outcomes (7)

• R0 Resection Rates in Borderline Resectable Pancreatic Cancer

  Up to 5 years

• Incidence of Grade 3 and 4 Toxicities for the 2 Chemotherapy Regimens That Occur After Cycle 1 Day 1

  Up to 5 years

• Ca19-9 Response to Neoadjuvant Chemotherapy

  Up to 5 years

• Time to Disease Progression

  Up to 5 years

• Measurement of Biomarkers (SPARC, RM1 and SMAD4) in Tissues

  Up to 5 years

Study Arms (2)

gemcitabine/nab-paclitaxel

EXPERIMENTAL

three cycles of treatment in the gemcitabine/nab-paclitaxel

Drug: gemcitabine/nab-paclitaxel

mFOLFIRINOX

EXPERIMENTAL

6 cycles in the mFOLFIRINOX

Drug: mFOLFIRINOX

Interventions

gemcitabine/nab-paclitaxel DRUG

three cycles of treatment in the gemcitabine/nab-paclitaxel

Also known as: Gemzar, ABRAXANE

gemcitabine/nab-paclitaxel

mFOLFIRINOX DRUG

6 cycles in the mFOLFIRINOX

Also known as: irinotecan, fluorouracil, oxaliplatin

mFOLFIRINOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must meet the following criteria within 28 days of randomization (unless otherwise indicated) to be enrolled in the protocol:
• Histologically or cytologically proven adenocarcinoma of the pancreas. If the patient has mixed tumor with predominant adenocarcinoma pathology, they can be enrolled.
• Subjects will be staged according to the 2010 American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-4, N0 being eligible; and have a primary tumor of the pancreas (either pancreatic head, neck, uncinate process, or body/tail)
• The tumor must be deemed as being borderline resectable. Final CT confirmation of surgical staging/ eligibility will be at the discretion of the pancreatic surgeon of the patient.
• Disease is confined to locoregional site as confirmed by the CT and / or diagnostic staging laparoscopy to avoid occult peritoneal deposits. Diagnostic laproscopy will be only if absolutely required
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT
• Screening Endoscopic ultrasound if done prior to consent but within 6 weeks of expected randomization date it may be used.
• Karnofsky performance status greater than or equal to 70 or Eastern Cooperative Oncology Group (ECOG) performance of 0-2.
• Age \> 18
• Estimated life expectance \> 12 weeks
• If female patient is of child bearing potential, she must have a negative serum pregnancy test (βhCG) documented up to 72hrs prior to administration of first study drug
• Patient has screening blood work performed which includes the following (should be drawn ≤ 14 days prior to randomization)
• absolute neutrophil count (ANC) \> 1.5 x 109/L
• Platelet count ≥ 100000/mm3
• Hemoglobin (HgB) ≥ 9g/dL

You may not qualify if:

• Ineligible Histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas
• Evidence of distant metastasis on upright chest x-ray, CT or other staging studies
• Subjects with recurrent disease
• Prior radiation therapy to the upper abdomen or liver at the discretion of the treating radiation oncologist could impair delivery of the prescribed radiation treatment
• Prior chemotherapy
• Subjects in their reproductive age who are breast feeding or have a positive pregnancy test
• Any co-morbid condition of sufficient severity to limit full compliance with the protocol per assessment by the individual treating physician
• Concurrent active infection
• Previous or current malignancies of other histologies within the last 3 yrs prior to randomization; with the exception of cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer
• Patient with known historical or active infection with HIV, Hepatitis B or Hepatitis C
• Patient who has undergone recent major surgery, other than diagnostic surgical procedure within 4 weeks prior to randomization.
• Patient who has a history of allergy or hypersensitivity to any of the study drugs.
• Patients with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
• Patients with greater than 2 screening peripheral neuropathy.

Sponsors & Collaborators

• Nathan Bahary, MD: lead

Study Sites (1)

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Gemcitabine; Albumin-Bound Paclitaxel; Irinotecan; Fluorouracil; Oxaliplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Camptothecin; Alkaloids; Uracil; Pyrimidinones; Coordination Complexes

Results Point of Contact

• Title: Nathan Bahary, MD
• Organization: University of Pittsburgh Cancer Institute

baharyn@upmc.edu

412-864-7764

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 16, 2014
• Study Start: December 1, 2014
• Primary Completion: March 3, 2017
• Study Completion: March 3, 2017
• Last Updated: July 26, 2018
• Results First Posted: June 15, 2018

Record last verified: 2018-06

Locations

US (1)