Pilot, Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery, Adenocarcinoma of the Pancreas
Verified November 2013 by Medical University of South Carolina
Information provided by (Responsible Party):
Melanie Thomas, Medical University of South Carolina
First received: September 10, 2012
Last updated: November 21, 2013
Last verified: November 2013
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.
Genetic: Genetic Expression
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Pilot Study of Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas
Primary Outcome Measures:
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
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
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.
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
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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
|Medical University of South Carolina
|Charleston, South Carolina, United States, 29425 |
|Contact: Melanie Thomas, MD 843-792-5329 email@example.com |
|Contact: Andie Adelman 843-792-1507 firstname.lastname@example.org |
|Principal Investigator: Melanie Thomas, MD |
Medical University of South Carolina
||Melanie Thomas, MD
||Medical University of South Carolina
No publications provided
||Melanie Thomas, Associate Professor, Medical University of South Carolina
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 10, 2012
||November 21, 2013
||United States: Institutional Review Board
Keywords provided by Medical University of South Carolina:
NEOADJUVANT GEMCITABINE AND ABRAXANE CHEMOTHERAPY
RESECTABLE ADENOCARCINOMA OF THE PANCREAS
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs