Pancreatic Resectability in Cancers With Known Limited Extension (PRICKLE) (PRICKLE)
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|ClinicalTrials.gov Identifier: NCT02124369|
Recruitment Status : Terminated (Poor accrual)
First Posted : April 28, 2014
Last Update Posted : July 16, 2019
Pancreatic cancer is difficult to treat, and even in a situation where an operation can be performed to remove the cancer, the disease can unfortunately come back soon afterwards. When pancreatic cancer is more advanced, the outcomes are even less positive. Recently, a large international study showed that combining a chemotherapy drug that is standard for treating pancreatic cancer, called gemcitabine with a new chemotherapy drug called Abraxane was more effective than gemcitabine alone for patients with advanced pancreatic cancer.
The purpose of this study is to determine whether this combination of gemcitabine and Abraxane can shrink a pancreatic cancer that is not thought to be operable enough to enable it to be removed by surgery. It is hoped that in this way, the treatment may improve the outcome. In addition, in this study we would like to analyse the appearances of the tumour using imaging, and collect blood and tumour samples to try to confirm laboratory research that has been carried out with this treatment.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Drug: Abraxane Drug: Gemcitabine||Phase 2|
This is a single-centre, non-randomised, phase 2a, single arm, Simon two-stage design trial of nab-paclitaxel and gemcitabine (ABX/GEM) in patients with histological documentation of pancreatic ductal adenocarcinoma (PDAC) who are determined by central radiological review to have "category 2" borderline unresectable LAPC. We will investigate the feasibility of administering ABX/GEM in terms of safety and efficacy, and will study activity both in terms of radiological response and the feasibility of downstaging patients to "category 1" status, in order to attempt resection after up to 6 cycles of combination treatment. In addition to adding to data on the safety and tolerability of this combination, peri- and post-operative morbidity following this treatment will be evaluated. As part of the trial, detailed correlative studies will be undertaken to evaluate the mechanism of action of the combination, at a tissue level, a circulating biomarker level and a radiological level.
We propose that the tumour shrinkage (response) seen in Stage IV pancreatic cancer patients as a result of ABX/GEM may translate to a realistic prospect of downstaging borderline unresectable LAPC tumours sufficiently to enable resection. Notionally, even in the absence of a classical partial response by RECIST criteria (≥30% reduction in sum of longest diameters) a beneficial outcome may arise from any tumour shrinkage sufficient to permit the tumour to be separated from major vessels thus rendering it resectable. Such an outcome may significantly alter the poor survival outcomes in this group of patients. The PRICKLE clinical study paradigm is useful for evaluating novel agents and combinations that show impressive activity in the pre-clinical or advanced setting and offers an opportunity for detailed correlative translational studies to evaluate activities of therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pancreatic Resectability in Cancers With Known Limited Extension (PRICKLE) - A Single-centre Phase 2a Study of Gemcitabine Plus Nab-paclitaxel for Borderline Unresectable Locally Advanced Pancreatic Cancer|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||December 2017|
Abraxane & gemictabine
Abraxane, IV, 125mg/m2 and gemcitabine, IV, 1000mg/m2, on days 1,8 & 15 per 28 day cycle, up to a maximum of 6 cycles.
125mg/m2, IV, on days 1,8 & 15 of each 28 day cycle, up to 6 cycles.
Other Name: nab-paclitaxel
1000mg/m2, IV, on days 1,8 & 15 of a 28 day cycle, up to 6 cycles.
Other Name: Gemzar
- Tumour resection rate [ Time Frame: 18 months ]Is the combination of ABX/GEM effective in shrinking LAPC tumours sufficiently to permit resection.
- Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: 18 months ]Determining the causality of Adverse Events and Serious Adverse Events
- Radiological response by percentage change [ Time Frame: 18 months ]Radiological response as determined by percentage change in sum of longest diameters for all target lesions at 3 or 6 months from the start of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02124369
|Cambridge, United Kingdom, CB2 0QQ|
|Principal Investigator:||Bristi Basu, Dr||Addenbrookes Hospital|