Study of Gemcitabine and Abraxane to Treat Potentially Operable Pancreatic Cancer

NCT01298011 | Completed Phase 2

• 1 other identifier: PCRT 10-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

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.

Conditions

Resectable Pancreatic Cancer

Keywords

operable; pancreas; Abraxane; Gemcitabine; Preoperative; potentially; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

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

  At time of surgery

Secondary Outcomes (7)

• Number of participants with adverse events.

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

• Tumor response rate to therapy.

  Baseline and 16 weeks

• Change in CA 19-9

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

• 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.

Study Arms (1)

Gemcitabine & Abraxane Pancreatic Cancer

EXPERIMENTAL

Drug: Gemcitabine and Abraxane

Interventions

Gemcitabine and Abraxane DRUG

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

Also known as: nab-paclitaxel, gemzar

Gemcitabine & Abraxane Pancreatic Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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);

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pancreatic Cancer Research Team: lead
• Celgene Corporation: collaborator

Study Sites (4)

TGen Clinical Research Services at Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

St Mary's / Trinity Health Care

Grand Rapids, Michigan, 49505, United States

Location

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55408, United States

Location

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 19047, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Ramesh K. Ramanathan, MD

  TGen Drug Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 17, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2015
• Last Updated: June 17, 2015

Record last verified: 2015-06

Locations

US (4)