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Study of Gemcitabine and Abraxane to Treat Potentially Operable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01298011
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : June 17, 2015
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Pancreatic Cancer Research Team

Tracking Information
First Submitted Date  ICMJE February 14, 2011
First Posted Date  ICMJE February 17, 2011
Last Update Posted Date June 17, 2015
Study Start Date  ICMJE May 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
Grade III/IV histological response in tumor specimen rate after induction therapy. [ Time Frame: At time of surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01298011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
  • Number of participants with adverse events. [ Time Frame: From the initial dose of study drug up to 28 days after last dose of study drug. ]
  • Tumor response rate to therapy. [ Time Frame: Baseline and 16 weeks ]
    Pre and post therapy radiological assessments of the primary tumor will be compared using RECIST criteria.
  • Change in CA 19-9 [ Time Frame: Baseline, Day 1 of each cycle, and end of therapy. ]
    Baseline CA19-9 and subsequent levels will be compared.
  • Resection rate at surgery [ Time Frame: At time of surgery ]
    The number of patients who have R0 and R1 surgery will be compiled.
  • Time to recurrence [ Time Frame: 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. ]
  • SPARC protein expression in tumor [ Time Frame: At time of surgery ]
  • Overall Survival [ Time Frame: Time from the first dose of study drug until date of death from any cause, up to 60 months. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Gemcitabine and Abraxane to Treat Potentially Operable Pancreatic Cancer
Official Title  ICMJE A Pilot Phase II Multi Center Study of Gemcitabine and Nab-paclitaxel (Abraxane) as Preoperative Therapy for Potentially Operable Pancreatic Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Resectable Pancreatic Cancer
Intervention  ICMJE Drug: Gemcitabine and Abraxane
3 treatments for gemcitabine and abraxane every 28-days for 3 months, prior to surgery.
Other Names:
  • nab-paclitaxel
  • gemzar
Study Arms  ICMJE Experimental: Gemcitabine & Abraxane Pancreatic Cancer
Intervention: Drug: Gemcitabine and Abraxane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2011)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

    Definition of potentially operable disease

    1. Staging by high-quality, pancreatic protocol, helical abdominal computed tomography required (Endoscopic ultrasound is not required).
    2. No extension to superior mesenteric artery (SMA) and hepatic artery.
    3. Clear fat plane between the SMA and celiac axis.
    4. No extension to celiac axis and hepatic artery.
    5. Patent superior mesenteric vein and portal vein.
    6. No evidence of distant or extra-hepatic disease by CT scans.
    7. Pretreatment histological or cytological confirmation of an adenocarcinoma.
  2. Male or non-pregnant and non-lactating female, and ≥ 18 years of age.
  3. 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.
  4. If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator.
  5. Patient must have received no prior chemotherapy or radiation for pancreatic cancer and no exposure to gemcitabine and/or Abraxane
  6. Patient has the following blood counts at baseline:

    1. ANC ≥ 1.5 x 109/L (1500 /mm³);
    2. Platelets ≥ 100 x 109/L; (100,000/mm³);
    3. Hgb ≥ 10 g/dL.
  7. Patient has the following blood chemistry levels at baseline:

    1. AST (SGOT), ALT (SGPT) ≤ 2.5 x upper limit of normal (ULN);
    2. Alkaline phosphatase (AP) ≤ 2.5 X ULN;
    3. Total bilirubin ≤1.5 mg/dl;
    4. Serum creatinine ≤1.5mg/dl or calculated clearance ≥ 50 mL/min/1.73 m² for patients with serum creatinine levels >1.5 mg/dl.
  8. Patient has acceptable coagulation status as indicated by a PT within normal limits (±15%) and PTT within normal limits (± 15%).
  9. Patient has an ECOG performance status PS 0-1.
  10. 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:

  1. Patient has borderline resectable disease
  2. Patient uses therapeutic coumadin for a history of pulmonary emboli or DVT.
  3. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  4. Patient has known infection with HIV, hepatitis B, or hepatitis C.
  5. 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.
  6. Prior chemotherapy or radiation for pancreatic cancer. Prior exposure to gemcitabine and/or Abraxane.
  7. Patient has a history of allergy or hypersensitivity to the study drugs.
  8. 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.
  9. Patient is unwilling or unable to comply with study procedures.
  10. Patient is enrolled in any other therapeutic clinical protocol or investigational trial.
  11. Patient has metastatic disease on radiological staging.
  12. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01298011
Other Study ID Numbers  ICMJE PCRT 10-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pancreatic Cancer Research Team
Study Sponsor  ICMJE Pancreatic Cancer Research Team
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: Ramesh K. Ramanathan, MD TGen Drug Development
PRS Account Pancreatic Cancer Research Team
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP