Status:
COMPLETED
Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer
Lead Sponsor:
Grupo Hospital de Madrid
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 surr...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01442974
Start Date
January 1 2011
End Date
June 1 2012
Last Update
March 13 2013
Active Locations (1)
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1
Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050