Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer

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Brief Title

Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer

Official Title

Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer

Brief Summary

      Targeting tumor stroma is emerging as a strategic approach for pancreatic cancer treatment.
      Actually, one of the most interesting characteristics of pancreatic cancer is the dense
      fibrotic stroma surrounding tumor cells. Moreover, pancreatic cancer stroma seems to express
      a specific protein profile different from tumor cells. For example, secreted protein rich in
      cysteine (SPARC) is overexpressed in pancreatic tumor stroma fibroblast and downregulated in
      tumor cells. This characteristic is associated with poor clinical outcome.

      Nab-paclitaxel, an albumin bound nano formulation of paclitaxel that targets SPARC, decreases
      tumor stroma density. Such effect improves drug delivery, and enhances both, nab-paclitaxel
      and gemcitabine, antitumor activity in nude mouse models.

      Based on this pre-clinical data the investigators designed a clinical trial of nab-paclitaxel
      in combination with gemcitabine as neo-adjuvant treatment for pancreatic cancer patients.
      Fifteen, SPARC positive patients, will be enrolled in the study and treated with abraxane in
      combination with gemcitabine.

      This is a pilot study which primary end point is evaluating the effect of Abraxane in
      combination with gemcitabine on tumor stroma, and the secondary end-point is correlating
      these changing with treatment activity.
    

Detailed Description

      Study Phase: Pilot study to assess nab-paclitaxel in combination with gemcitabine effects on
      pancreatic cancer stroma and tumor metabolism.

      Study Objective(s):

      A) Primary end-points:

        1. Evaluate the effect of nab-paclitaxel in combination with gemcitabine on tumor stroma
           density.

        2. Evaluate the effect of nab-paclitaxel on tumor vessels formation.

        3. Evaluate the effect of nab-paclitaxel on tumor metabolism.

      B) Secondary end-point:

      1. Evaluate combination activity in relation with changes in tumor stroma and tumor metabolic
      activity.

      The following studies will be performed prior and after treatment administration:

        -  18FDG-PET/CT scan;

        -  Ultrasound Elastography;

        -  IHC:

             1. SPARC;

             2. Microvessel Density (CD-31, VEGF-A);

             3. Stroma density (SMA and Collagen I).

      Study population and Number of subject: A total of 15 pancreatic cancer patients with
      resectable/resectable borderline disease are expected to be enrolled.

      Study design and schedule: This is a pilot study to evaluate the effect of nab-paclitaxel on
      tumor stroma in pancreatic cancer patients. The study will be conducted in two parts:

      Part A: Patients diagnosed with resectable/resectable pancreatic cancer will be screened for
      SPARC expression. Fifteen, SPARC positive patients, will be enrolled in the study and treated
      with nab-paclitaxel in combination with gemcitabine. Patients will be treated as follow:

        -  nab-paclitaxel will be administered at 125 mg/m2 as intravenous (i.v.) infusion over 30
           minutes;

        -  followed by gemcitabine 1000 mg/m2 i.v. infusion over 30 minutes;

      Treatment will be delivered weekly, for 3 weeks (on day 1, 8, and 15 over 28 days cycle)
      followed by a week of rest, for two cycles of treatment.

      Part B: At the end of treatment tumors will be surgically resected according to standard
      surgical procedure for the treatment of pancreatic cancer.
    


Study Type

Interventional


Primary Outcome

Effect of nab-paclitaxel on pancreatic cancer stroma, new vessel formation and tumor cell metabolism.

Secondary Outcome

 Activity of nab-paclitaxel in combination with gemcitabine against PDA in relation with changes in tumor stroma and tumor metabolic activity.

Condition

Pancreatic Cancer

Intervention

Gemcitabine plus nab-paclitaxel

Study Arms / Comparison Groups

 Gemcitabine plus nab-paclitaxel
Description:  This is a single arm study.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

15

Start Date

January 2011

Completion Date

June 2012

Primary Completion Date

January 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Patients who are 18 years or older;

          -  Patients with resectable/resectable borderline pancreatic cancer;

          -  Adequate hematopoietic, hepatic and renal function:

               -  Neutrophil count > o = 1.5 x 109/L;

               -  Platelet count > o = 100 x 109/L;

               -  Bilirubin ≤ 1.5 x ULN;

               -  AST and/or ALT ≤ 2.5 x ULN;

               -  Serum creatinine ≤ 1.5 x ULN.

          -  Investigators must ensure that patients enrolled in the study will be available for
             all study procedures, including tumor biopsy, surgical treatment, and follow up.

          -  Investigators must ensure that patients have the ability to understand the
             requirements of the study and provide signed informed consent.

          -  Signed Informed Consent.

        Exclusion Criteria:

          -  Active or uncontrolled infections or serious illnesses or medical conditions that
             could interfere with patient eligibility for treatment;

          -  History of any psychiatric condition that might impair patient's ability to understand
             or to comply with the requirements of the study or to provide informed consent;

          -  Concurrent anticancer therapy;

          -  Pregnant or breast-feeding women (documented methods of birth control are required in
             those with reproductive potential);

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to study drugs;

          -  History of life threatening reaction to gemcitabine or abraxane;

          -  Previous exposure to other agents or treatment procedure as radiotherapy for the
             treatment of pancreatic cancer.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Manuel Hidalgo, MD, PhD, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT01442974

Organization ID

ABX271-PA09EU


Responsible Party

Principal Investigator

Study Sponsor

Grupo Hospital de Madrid


Study Sponsor

Manuel Hidalgo, MD, PhD, Principal Investigator, Centro Integral Oncologico Clara Campal (CIOCC), Centro National Investigacion Oncologica (CNIO)


Verification Date

March 2013