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

Pancreatic Cancer Research Team4 sites in 1 country25 target enrollmentMay 2011

ConditionsResectable Pancreatic Cancer

InterventionsGemcitabine and Abraxane

DrugsGemcitabine and Abraxane

Overview

Phase: Phase 2
Intervention: Gemcitabine and Abraxane
Conditions: Resectable Pancreatic Cancer
Sponsor: Pancreatic Cancer Research Team
Enrollment: 25
Locations: 4
Primary Endpoint: Grade III/IV histological response in tumor specimen rate after induction therapy.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

May 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pancreatic Cancer Research Team

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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.

Exclusion Criteria

•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.
•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.

Arms & Interventions

Gemcitabine & Abraxane Pancreatic Cancer

Intervention: Gemcitabine and Abraxane

Outcomes

Primary Outcomes

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

Time Frame: At time of surgery

Secondary Outcomes

SPARC protein expression in tumor(At time of surgery)
Overall Survival(Time from the first dose of study drug until date of death from any cause, up to 60 months.)
Number of participants with adverse events.(From the initial dose of study drug up to 28 days after last dose of study drug.)
Resection rate at surgery(At time of surgery)
Time to recurrence(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.)
Tumor response rate to therapy.(Baseline and 16 weeks)
Change in CA 19-9(Baseline, Day 1 of each cycle, and end of therapy.)