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Resectable Pancreatic CancerPhase 2NCT01298011

Study of Gemcitabine and Abraxane to Treat Potentially Operable Pancreatic Cancer

A Phase 2 study testing Gemcitabine and Abraxane in people with Resectable Pancreatic Cancer, run by Pancreatic Cancer Research Team at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this research study is to evaluate whether Abraxane and gemcitabine are effective in treating patients with operable pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Resectable Pancreatic Cancer
What is being tested?
Gemcitabine and Abraxane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
4 sitesUnited States
Study dates
May 2011to May 2015
Phase
Phase 2
Are there results?
None posted in the registry

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. Patients with islet cell neoplasms are excluded.
  • Definition of potentially operable disease
  • Staging by high-quality, pancreatic protocol, helical abdominal computed tomography required (Endoscopic ultrasound is not required).
  • No extension to superior mesenteric artery (SMA) and hepatic artery.
  • 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 or extra-hepatic disease by CT scans.
  • Pretreatment histological or cytological confirmation of an adenocarcinoma.
  • Male or non-pregnant and non-lactating female, and ≥ 18 years of age.
  • If a female patient is of child-bearing potential, she must have a negative serum pregnancy test (β hCG) 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 have received no prior chemotherapy or radiation for pancreatic cancer and no exposure to gemcitabine and/or Abraxane
  • Patient has the following blood counts at baseline:
  • ANC ≥ 1.5 x 109/L (1500 /mm³);
  • Platelets ≥ 100 x 109/L; (100,000/mm³);
  • Hgb ≥ 10 g/dL.
  • Patient has the following blood chemistry levels at baseline:
  • AST (SGOT), ALT (SGPT) ≤ 2.5 x upper limit of normal (ULN);
  • Alkaline phosphatase (AP) ≤ 2.5 X ULN;
  • Total bilirubin ≤1.5 mg/dl;
  • Serum creatinine ≤1.5mg/dl or calculated clearance ≥ 50 mL/min/1.73 m² for patients with serum creatinine levels >1.5 mg/dl.
  • Patient has acceptable coagulation status as indicated by a PT within normal limits (±15%) and PTT within normal limits (± 15%).
  • Patient has an ECOG performance status PS 0-1.
  • 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 disease
  • Patient uses therapeutic coumadin for a history of pulmonary emboli or DVT.
  • Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  • Patient has known infection with HIV, hepatitis B, or hepatitis C.
  • 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.
  • Prior chemotherapy or radiation for pancreatic cancer. Prior exposure to gemcitabine and/or Abraxane.
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  • 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 an experimental research drug.
  • Patient is unwilling or unable to comply with study procedures.
  • Patient is enrolled in any other therapeutic clinical protocol or investigational trial.
  • Patient has metastatic disease on radiological staging.
  • Patients aged ≥ 80 are not excluded. As two events of fatal sepsis have been seen in this group in other studies, candidates in this age group should be thoroughly evaluated before enrollment in the study, to ensure they are fit to receive chemotherapy. 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 as to receive repeat weekly 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

4 sites in 1 country.

United States4 sites

  • St Mary's / Trinity Health Care

    Grand Rapids, Michigan, 49505

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55408

  • University of Pittsburg Medical Center

    Pittsburgh, Pennsylvania, 19047

  • TGen Clinical Research Services at Scottsdale Healthcare

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Pilot Phase II Multi Center Study of Gemcitabine and Nab-paclitaxel (Abraxane) as Preoperative Therapy for Potentially Operable Pancreatic Cancer

The main purpose of this research study is to evaluate whether Abraxane and gemcitabine are effective in treating patients with operable pancreatic cancer.

Read the detailed description

The best outcome for a patient diagnosed with pancreatic cancer is surgery. However many patients have recurrence of the cancer after successful surgery. The investigators are evaluating chemotherapy before surgery, which is a new approach.

In this study, Abraxane and gemcitabine will be tested as treatment for people with operable pancreatic cancer to see if surgery can be successfully performed and if treatment will reduce cancer cells in the tumor at surgery.

Abraxane is approved by the US FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Gemcitabine is approved by the FDA for first line treatment for patients with locally advanced or metastatic cancer of the pancreas.

Being tested
Gemcitabine and Abraxane
Keywords
operable, pancreas, Abraxane, Gemcitabine, Preoperative, potentially, Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Gemcitabine and AbraxaneDrug

    Also called nab-paclitaxel, gemzar

    3 treatments for gemcitabine and abraxane every 28-days for 3 months, prior to surgery.

Study groups in NCT01298011
Study groupRoleWhat they receive
Gemcitabine & Abraxane Pancreatic CancerExperimentalNot described
Receives: Drug: Gemcitabine and Abraxane

What is being measured

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

  1. Grade III/IV histological response in tumor specimen rate after induction therapy.

    Measured: At time of surgery

Secondary outcomes (7)

  1. Number of participants with adverse events.

    Measured: From the initial dose of study drug up to 28 days after last dose of study drug.

  2. Tumor response rate to therapy.

    Pre and post therapy radiological assessments of the primary tumor will be compared using RECIST criteria.

    Measured: Baseline and 16 weeks

  3. Change in CA 19-9

    Baseline CA19-9 and subsequent levels will be compared.

    Measured: Baseline, Day 1 of each cycle, and end of therapy.

  4. Resection rate at surgery

    The number of patients who have R0 and R1 surgery will be compiled.

    Measured: At time of surgery

  5. Time to recurrence

    Measured: Time from first dose of study drug to date of first documented progression or date of death, whichever occurs first, assessed up to 60 months.

  6. SPARC protein expression in tumor

    Measured: At time of surgery

  7. Overall Survival

    Measured: Time from the first dose of study drug until date of death from any cause, up to 60 months.

Timeline

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

  1. First posted17 Feb 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2013
  4. Study completionMay 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01298011
Sponsor's protocol ID
PCRT 10-001
Status last verified
Jun 2015
First submitted
14 Feb 2011
Last updated
17 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine and Abraxane in people with Resectable Pancreatic Cancer, run by Pancreatic Cancer Research Team at 4 sites 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 25 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: finished, as of the sponsor's last update on 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Grade III/IV histological response in tumor specimen rate after induction therapy. (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 NCT01298011.

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 17 Jun 2015.

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