Pancreatic CancerNCT01442974
Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer
A study testing Gemcitabine plus nab-paclitaxel in people with Pancreatic Cancer, run by Grupo Hospital de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine plus nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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):
- Primary end-points:
- Evaluate the effect of nab-paclitaxel in combination with gemcitabine on tumor stroma density.
- Evaluate the effect of nab-paclitaxel on tumor vessels formation.
- Evaluate the effect of nab-paclitaxel on tumor metabolism.
- Secondary end-point:
- 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:
- SPARC;
- Microvessel Density (CD-31, VEGF-A);
- 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine plus nab-paclitaxel
- Keywords
- nab-paclitaxel, neoadjuvant treatment, SPARC, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine plus nab-paclitaxelDrug
Also called Gemzar, 2'-deoxy-2',2''-difluorocytidine-5'-O-monophosphate, Abraxane, ABI007
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
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine plus nab-paclitaxel | Experimental | This is a single arm study. Receives: Drug: Gemcitabine plus nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of nab-paclitaxel on pancreatic cancer stroma, new vessel formation and tumor cell metabolism.
Primary End-point:
- Evaluate the effect of nab-paclitaxel in combination with gemcitabine on tumor stroma density.
- Evaluate the effect of nab-paclitaxel on tumor vessels formation.
- Evaluate the effect of nab-paclitaxel on tumor metabolism by PET-CT scan measuring pre-treatment versus post-treatment glucose uptake.
Measured: 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.
To assess secondary end-point the following studies will be performed
- 18FDG-PET/CT scan;
- Ultrasound Elastography;
- IHC:
- SPARC;
- Microvessel Density (CD-31, VEGF-A);
- Stroma density (SMA and Collagen I).
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Hospital de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Perea, Director Clinical Trials Unit., Grupo Hospital de Madrid
- Investigators
- Manuel Hidalgo, MD, PhD, Principal investigator, Centro Integral Oncologico Clara Campal (CIOCC), Centro National Investigacion Oncologica (CNIO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442974
- Sponsor's protocol ID
- ABX271-PA09EU
- Status last verified
- Mar 2013
- First submitted
- 13 Jun 2011
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01442974
- Acronym / sponsor ID
- ABX271-PA09EU
- Conditions
- Pancreatic Cancer
- Keywords
- nab-paclitaxel, neoadjuvant treatment, SPARC, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Grupo Hospital de MadridUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- Primary end-points:
- Evaluate the effect of nab-paclitaxel in combination with gemcitabine on tumor stroma density.
- Evaluate the effect of nab-paclitaxel on tumor vessels formation.
- Evaluate the effect of nab-paclitaxel on tumor metabolism.
- Secondary end-point:
- 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:
- SPARC;
- Microvessel Density (CD-31, VEGF-A);
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine plus nab-paclitaxel | Experimental | Drug: Gemcitabine plus nab-paclitaxelThis is a single arm study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients who are 18 years or older;
- Patients with resectable/resectable borderline pancreatic cancer;
- Adequate hematopoietic, hepatic and renal function:
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine plus nab-paclitaxelAlso: Gemzar, 2'-deoxy-2',2''-difluorocytidine-5'-O-monophosphate, Abraxane, ABI007Gemcitabine 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 | Drug | Gemcitabine plus nab-paclitaxel |
Primary outcome
Effect of nab-paclitaxel on pancreatic cancer stroma, new vessel formation and tumor cell metabolism.
Time frame: up to 18 months
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.
1 secondary outcome
Activity of nab-paclitaxel in combination with gemcitabine against PDA in relation with changes in tumor stroma and tumor metabolic activity.
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Hidalgo, MD, PhD principal investigator
Centro Integral Oncologico Clara Campal (CIOCC), Centro National Investigacion Oncologica (CNIO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gemcitabine plus nab-paclitaxel in people with Pancreatic Cancer, run by Grupo Hospital de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of nab-paclitaxel on pancreatic cancer stroma, new vessel formation and tumor cell metabolism. (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2013.