Pancreatic Resectability in Cancers With Known Limited Extension (PRICKLE)

NCT02124369 | Terminated Phase 2

• 2 other identifiers: PRICKLE2013-004200-19
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Adenocarcinoma

Keywords

Pancreatic cancer; locally advanced; unresectable

Outcome Measures

Primary Outcomes (1)

• Tumour resection rate

  Is the combination of ABX/GEM effective in shrinking LAPC tumours sufficiently to permit resection.

  18 months

Secondary Outcomes (1)

• Number of Participants with Serious and Non-Serious Adverse Events

  18 months

Other Outcomes (1)

• Radiological response by percentage change

  18 months

Study Arms (1)

Abraxane & gemictabine

OTHER

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.

Drug: Abraxane; Drug: Gemcitabine

Interventions

Abraxane DRUG

125mg/m2, IV, on days 1,8 \& 15 of each 28 day cycle, up to 6 cycles.

Also known as: nab-paclitaxel

Abraxane & gemictabine

Gemcitabine DRUG

1000mg/m2, IV, on days 1,8 \& 15 of a 28 day cycle, up to 6 cycles.

Also known as: Gemzar

Abraxane & gemictabine

Eligibility Criteria

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

You may qualify if:

• Patients with borderline unresectable advanced pancreatic adenocarcinoma, defined as Category 2 by central radiological review.
• Aged 18 years or over at the time of signing the informed consent form.
• Documented histological or cytological diagnosis of pancreatic ductal adenocarcinoma.
• ECOG performance status 0-1.
• Life expectancy of at least 12 weeks.
• Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
• Adequate haematological function defined by:
• Absolute neutrophil count (ANC) ≥1,500 cells/mm3 (1.5 x 109/L).
• Haemoglobin ≥8.0 g/dL (80 g/L) (may be increased to this level with transfusion as long as there is no evidence of active bleeding).
• Platelets ≥100x 109/L
• Adequate renal function defined by serum creatinine≤1.5 x ULN or calculated creatinine clearance by Cockcroft-Gault of ≥50 ml/min.
• Adequate hepatic function defined by:
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN)
• Total bilirubin ≤1.5 x ULN
• Patients may have endoscopic or radiologic stenting to treat biliary obstruction. If so, bilirubin must return to ≤1.5 x ULN prior to enrolment.

You may not qualify if:

• Patients with metastatic PDAC, or disease which is amenable to resection with curative intent. These include tumours which are defined as Category 1 or 3 by central radiological review.
• Other invasive malignancies diagnosed within the last 5 years, with the exceptions of adequately treated localized cured prostate cancer, in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for three years or more and are deemed at negligible risk for recurrence, are eligible for the trial.
• Known allergy or hypersensitivity to ABX or GEM.
• Routine use of oral anti-oxidant supplements: beta-carotene, selenium, lutein, zeaxanthin, lycopene, pycnogenol, fernblock, omega-3S, vitamin C, vitamin E, astaxanthin. If recent use, a washout period of 5 half-lives is required.
• Patients with pre-existent ischemic heart disease particularly those under active treatment for coronary disease, will be excluded from Sonuvue dynamic contrast enhanced ultrasound investigation due to sporadic reports of cardiac ischemia in this population. They will be eligible for the rest of the study, as long as their cardiac status does not preclude surgery.
• Significant acute or chronic medical or psychiatric condition, disease or laboratory abnormality which in the judgment of the Investigator would place the patient at undue risk or interfere with the study. Examples include, but are not limited to:
• Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation who are not appropriately anti-coagulated or have had a NCI CTCAE (version 4.0) Grade 2 or greater bleeding episode in the 4 weeks before Day 1.
• Patients taking warfarin, unless it is possible for the patient to be switched to a low molecular weight heparin for the duration of the study
• Patients with a significant history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
• Cirrhotic liver disease, ongoing alcohol abuse, or known chronic active or acute hepatitis B, or hepatitis C.
• Known infection with HIV.
• Women, who are pregnant, plan to become pregnant or are lactating (during the study or for up to 6 months after the last dose).

Sponsors & Collaborators

• CCTU- Cancer Theme: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• Cancer Research UK: collaborator
• Celgene: collaborator

Study Sites (1)

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Related Links

• Pancreatic Cancer UK
• CancerHelp UK from Cancer Research UK
• Cancer Backup
• Macmillan Cancer Support

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bristi Basu, Dr

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Bristi Basu

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 28, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 16, 2019

Record last verified: 2019-07

Locations

GB (1)