CompletedPhase 2

Study of Gemcitabine and Abraxane to Treat Potentially Operable Pancreatic Cancer

United States25 participantsStarted 2011-05

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient has histologically or cytologically confirmed potentially resectable adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded.
✓. 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.

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.

What they're measuring

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

Timeframe: At time of surgery

Trial details

NCT IDNCT01298011

SponsorPancreatic Cancer Research Team

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Resectable Pancreatic Cancer trials