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Borderline Resectable Pancreatic CancerPhase 2NCT02241551

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

A Phase 2 study testing gemcitabine/nab-paclitaxel and mFOLFIRINOX in people with Borderline Resectable Pancreatic Cancer, run by Nathan Bahary, MD at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Borderline Resectable Pancreatic Cancer
What is being tested?
gemcitabine/nab-paclitaxel and mFOLFIRINOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Dec 2014to 3 Mar 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • aspartate aminotransferase (AST),Alanine Aminotransferase (ALT)≤ 2.5 x upper limit of normal (ULN) Total Bilirubin ≤ ULN
  • Serum Cr within normal limits (WNL)
  • Coagulation studies with Prothrombin Time and International Normalized Ratio (PT/INR) and partial thromboplastin time (PTT) within normal limits (±15%). • Patient has a urinalysis obtained (≤14 days prior to randomization) and the results are deemed not clinically significant by the investigator.
  • Patient has no evidence of jaundice at the time of enrolment. If stent is required to alleviate jaundice, it should be metallic. If patient has a previously placed stent and this is plastic, this should be changed to metallic.
  • Patient's pain symptoms have remained stable with no adjustment to analgesics within 7 days prior to randomization. Patient must be able to swallow entreat medications with no requirement for a feeding tube. Patient's must not have intractable nausea or vomiting which prohibits the patient from oral medications
  • Diabetes must be controlled prior to enrollment
  • Disease must be encompassed in a reasonable SBRT "portal" as defined by the treating radiation oncologist

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

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

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.

Being tested
gemcitabine/nab-paclitaxel, mFOLFIRINOX
Keywords
Borderline, Resectable, Pancreatic, Cancer, Neoadjuvant, Chemotheraphy, Gemcitabine, Nab-Paclitaxel, mFOFIRINOX, Sterotatic Body Radiation Therapy
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gemcitabine/nab-paclitaxelDrug

    Also called Gemzar, ABRAXANE

    three cycles of treatment in the gemcitabine/nab-paclitaxel

  • mFOLFIRINOXDrug

    Also called irinotecan, fluorouracil, oxaliplatin

    6 cycles in the mFOLFIRINOX

Study groups in NCT02241551
Study groupRoleWhat they receive
gemcitabine/nab-paclitaxelExperimentalthree cycles of treatment in the gemcitabine/nab-paclitaxel
Receives: Drug: gemcitabine/nab-paclitaxel
mFOLFIRINOXExperimental6 cycles in the mFOLFIRINOX
Receives: Drug: mFOLFIRINOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 5 years

Secondary outcomes (7)

  1. R0 Resection Rates in Borderline Resectable Pancreatic Cancer

    Measured: Up to 5 years

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

    According to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTAE, v4.0)

    Measured: Up to 5 years

  3. Ca19-9 Response to Neoadjuvant Chemotherapy

    Measured: Up to 5 years

  4. Time to Disease Progression

    Measured: Up to 5 years

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

    This wil be measured in tissues that are obtained at screening and in the resected tumour specimen

    Measured: Up to 5 years

  6. Radiological Response Rate to Therapy

    Radiological improvements will be evaluated by determining changes in density of measurable disease on CT scan pre and post chemotherapy

    Measured: Up to 5 years

  7. Quality of Life Effects of Chemotherapy on Patients Receiving Chemotherapy and SBRT

    This will be measured using the FACT-HB questionaire

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion3 Mar 2017
  4. Study completion3 Mar 2017

Why it stopped: Study was terminated with the IRB ended early as logistical concerns of the SBRT

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02241551
Sponsor's protocol ID
UPCI 13-143
Status last verified
Jun 2018
First submitted
29 Aug 2014
Last updated
26 Jul 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine/nab-paclitaxel and mFOLFIRINOX in people with Borderline Resectable Pancreatic Cancer, run by Nathan Bahary, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02241551.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.

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