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Adenocarcinoma PancreasEarly Phase 1NCT01783054

Pilot, Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery, Adenocarcinoma of the Pancreas

A Early Phase 1 study testing Surgery, Genetic Expression and Chemotherapy in people with Adenocarcinoma Pancreas, run by Medical University of South Carolina 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 study is for adult patients with adenocarcinoma of the pancreas. The purpose of this research study is to evaluate the safety and effectiveness of the drugs Gemcitabine and Abraxane in the treatment of adenocarcinoma of the pancreas before surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenocarcinoma Pancreas
What is being tested?
Surgery, Genetic Expression and Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Jul 2012to Oct 2015
Phase
Early Phase 1
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

  • Patient has histologically or cytologically confirmed potentially resectable adenocarcinoma of the pancreas including tumors in the pancreatic head, uncinate process, neck, body and tail that are potentially resectable by pancreatico-duodenectomy (Kausch-Whipple procedure). Patients with islet cell or other neuroendocrine neoplasms are excluded.
  • Definition of localized, potentially resectable disease:
  • Staging by intravenous contrast-enhanced thin section helical abdominal computed tomography (2.5 mm cuts or less) or MRI (for patients with an IV contrast allergy) using pancreatic protocol. Endoscopic ultrasound is required for tissue acquisition and staging confirmation.
  • No extension to superior mesenteric artery (SMA) and hepatic artery. Patent superior mesenteric vein/portal vein (SMV/PV) with < 180-degree abutment and no evidence of invasion.
  • Clear fat plane between the SMA and celiac axis.
  • No extension to celiac axis and hepatic artery.
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  • Patent superior mesenteric vein and portal vein.
  • No evidence of distant disease.
  • Male or non-pregnant and non-lactating female, and ≥ 18 years of age.
  • If a female patient is of childbearing potential, she must have a negative serum pregnancy test documented within 72 hours of the first administration of study drug.
  • If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator.
  • Patient must not have received prior chemotherapy or radiation for pancreatic cancer.
  • Patient has the acceptable blood counts as outlined in the protocol.
  • Patient has an ECOG performance status PS 0-2.
  • Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to participation in any study-related activities.

Who cannot join

  • Patient has borderline resectable, locally advanced unresectable or advanced metastatic disease. Patients with adenocarcinoma of the distal pancreatic body or tail are ineligible. Patients with endocrine tumors, lymphoma of the pancreas, or ampullary cancer are also ineligible.
  • Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  • Patient has known infection with HIV.
  • Patient has undergone major surgery, other than diagnostic surgery (i.e.surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
  • Patient has a history of allergy or hypersensitivity to the study drugs.
  • Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapy.
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  • Patients requires chronic use of immunosuppressive agents (e.g. methotrexate, cyclosporine).
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years.
  • Patients must not have clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) < 1 year before randomization.
  • Patient is unwilling or unable to comply with study procedures.
  • Patient is enrolled in any other therapeutic clinical protocol or investigational trial.
  • Patients aged ≥ 80 are not excluded. However, candidates in this age group should be thoroughly evaluated before enrollment in the study, to ensure they are fit to receive chemotherapy, and to potentially undergo pancreaticoduodenectomy. In addition to meeting all of the baseline patient selection criteria, clinical judgment on their susceptibility to infection and expected stability of their performance status and suitability to receive intensive chemotherapy cycles, should be paid special attention to. Patients should not be enrolled in the study should there be any hesitation on any of these considerations. Baseline criteria for all patients enrolled on the study must be carefully evaluated and all criteria followed appropriately.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Pilot Study of Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas

This study is for adult patients with adenocarcinoma of the pancreas. The purpose of this research study is to evaluate the safety and effectiveness of the drugs Gemcitabine and Abraxane in the treatment of adenocarcinoma of the pancreas before surgery. Subjects will have screening tests to determine if he or she is eligible to participate in this study.

Read the detailed description

If subjects are eligible and wish to enroll in the study, they will begin chemotherapy treatment with Gemcitabine and Abraxane. After subjects have received treatment with these drugs, they will have surgery. Subjects will also have post treatment and follow up evaluations. Subjects may have 2 cycles of treatment and each cycle is 28 days. All subjects will be followed every 3 months for 3 years after their initial registration.

Being tested
Surgery, Genetic Expression, Chemotherapy
Keywords
NEOADJUVANT GEMCITABINE AND ABRAXANE CHEMOTHERAPY, SURGERY, RESECTABLE ADENOCARCINOMA OF THE PANCREAS

What participants receive

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

  • SurgeryProcedure or surgery

    Subjects will then receive surgery at MUSC within 4-8 weeks following completion of chemotherapy

  • Genetic ExpressionGenetic

    Subjects will have genetic expression testing done on their tissue samples.

  • ChemotherapyDrug

    Also called Gemcitabine, Abraxane

    Patients will receive gemcitabine at 1000 mg/m2 and abraxane at 125 mg/m2 intravenously on days 1, 8 and 15 of a 28 day cycle for 2 cycles

Study groups in NCT01783054
Study groupRoleWhat they receive
chemotherapy, surgery, genetic expressionExperimentalAll patients enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Treatment will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks. Patients will move on to surgery, 4-8 weeks after chemotherapy treatment. Patients must be recovered from any adverse effects of the chemotherapy before proceeding with surgery. As part of this study, tissue samples will be collect from each patient at the time of surgery for gene expression testing
Receives: Procedure: Surgery; Genetic: Genetic Expression; Drug: Chemotherapy

What is being measured

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

  1. Tumor Response

    Estimate the rate of good histopathologic tumor response to neoadjuvant chemotherapy assessed in resection specimen. A good response is defined as a grade III or IV histopathologic appearance, equivalent to <10% viable tumor.

    Measured: at time of surgery

Secondary outcomes (4)

  1. Number of Participants With R0 Resection Status.

    R0 resection status is a macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor.

    Measured: at time of surgery

  2. Estimate Median Time to Recurrence.

    Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.

    Measured: 2 years

  3. Estimate Median Overall Survival

    Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.

    Measured: 2 years

  4. Number of Adverse Events Reported in Subjects Enrolled.

    Assess the safety profile of this neoadjuvant regimen in patients with localized pancreatic adenocarcinoma. All toxicities will be reported by type and grade and tabulated. All adverse events will be reported via case report forms. The intensity of any adverse event should be reported according to the NCI Common Terminology Criteria for Adverse Events v4.0.

    Measured: First study drug administration until end of study

Timeline

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

  1. First posted4 Feb 2013 (estimated)
  2. Study startJul 2012
  3. Primary completionOct 2015

Why it stopped: Study terminated due to low accrual

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01783054
Sponsor's protocol ID
101826
Status last verified
Oct 2015
First submitted
10 Sep 2012
Last updated
8 Mar 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Surgery, Genetic Expression and Chemotherapy in people with Adenocarcinoma Pancreas, run by Medical University of South Carolina 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 15 inclusion and 12 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 8 Mar 2016. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 9 Nov 2015). 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?

Tumor Response (time frame: at time of surgery). 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 NCT01783054.

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 8 Mar 2016.

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