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

NCT01442974 | Completed DMC

• 1 other identifier: ABX271-PA09EU
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

nab-paclitaxel; neoadjuvant treatment; SPARC; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

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

  Primary End-point: 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 by PET-CT scan measuring pre-treatment versus post-treatment glucose uptake.

  up to 18 months

Secondary Outcomes (1)

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

  up to 18 months

Study Arms (1)

Gemcitabine plus nab-paclitaxel

EXPERIMENTAL

This is a single arm study.

Drug: Gemcitabine plus nab-paclitaxel

Interventions

Gemcitabine plus nab-paclitaxel DRUG

Gemcitabine 1000mg/mq on d1,8,15 over 28 days of cycle nab-paclitaxel 125mg/mq on d1,8,15 over 28 days cycle Treatment will be administered for two cycles

Also known as: Gemzar, 2'-deoxy-2',2''-difluorocytidine-5'-O-monophosphate, Abraxane, ABI007

Gemcitabine plus nab-paclitaxel

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grupo Hospital de Madrid: lead

Study Sites (1)

Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; 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

• Manuel Hidalgo, MD, PhD

  Centro Integral Oncologico Clara Campal (CIOCC), Centro National Investigacion Oncologica (CNIO)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Clinical Research Unit

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: September 29, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 13, 2013

Record last verified: 2013-03

Locations

ES (1)