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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Melanie Thomas, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01783054
First received: September 10, 2012
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma Pancreas
Procedure: Surgery
Genetic: Genetic Expression
Drug: Chemotherapy
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Tumor Response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Estimate the rate of good histopathologic tumor response to neoadjuvant chemotherapy assessed in resection specimen


Secondary Outcome Measures:
  • Safety Profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    • Estimate the R0 resection rate.
    • Estimate median time to recurrence.
    • Estimate median overall survival.
    • Assess the safety profile of this neoadjuvant regimen in patients with localized pancreatic adenocarcinoma.


Other Outcome Measures:
  • Tumor Expression [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To evaluate tumor expression of a panel of biomarkers, including the Sphingome array and SPARC (secreted protein acid rich in cysteine) expression in tumor, that may predict response to neoadjuvant chemotherapy.


Estimated Enrollment: 12
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemotherapy, surgery, genetic expression

All 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

Procedure: Surgery
Subjects will then receive surgery at MUSC within 4-8 weeks following completion of chemotherapy
Genetic: Genetic Expression
Subjects will have genetic expression testing done on their tissue samples.
Drug: Chemotherapy
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
Other Names:
  • Gemcitabine
  • Abraxane

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has histologically or cytologically confirmed potentially resectable adenocarcinoma of the pancreas including tumors in the pancreatic head, uncinate process, neck and body 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.
  • 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 following blood counts at baseline:
  • ANC ≥ 1.5 x 10^9/L (1500 /mm³);
  • Platelets ≥ 100 x 10^9/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 ≤ 2.0mg/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. For patients not receiving anticoagulation: International Normalized Ratio of a measure of prothrombin time (INR) < 1.3.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783054

Contacts
Contact: Melanie Thomas, MD 843-792-5329 thomasmb@musc.edu
Contact: Andie Adelman 843-792-1507 adelman@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Melanie Thomas, MD    843-792-5329    thomasmb@musc.edu   
Contact: Andie Adelman    843-792-1507    adelman@musc.edu   
Principal Investigator: Melanie Thomas, MD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Melanie Thomas, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Melanie Thomas, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01783054     History of Changes
Other Study ID Numbers: 101826
Study First Received: September 10, 2012
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
NEOADJUVANT GEMCITABINE AND ABRAXANE CHEMOTHERAPY
SURGERY
RESECTABLE ADENOCARCINOMA OF THE PANCREAS

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancrelipase
Gemcitabine
Paclitaxel
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 23, 2014