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Circulating Tumor Cells as Tools for Therapy Response in Nab-paclitaxel Treated Metastatic Pancreatic Cancer Patients (PACT-ACT-v6)

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ClinicalTrials.gov Identifier: NCT02707159
Recruitment Status : Unknown
Verified March 2016 by Helse Stavanger HF.
Recruitment status was:  Recruiting
First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF

Brief Summary:
The majority patients diagnosed with pancreatic cancer have metastatic disease at the time of diagnosis. The prognosis is extremely poor with a 5-year survival rate of less than 5%. Treatment with chemotherapy can improve efficacy, but still the median progression-free survival in patients receiving nab-paclitaxel and gemcitabine is only 5,5 months and median overall survival is less than one year. There is a urgent need for tools for predicting the efficacy of the treatment. The current trial aims at investigating the biomarker potential of circulating tumor cells (CTCs) in metastatic pancreatic cancer patients treated by gemcitabine and nab-paclitaxel.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: Nab paclitaxel / gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Novel Therapy for Locally Advanced and Metastatic Pancreatic Cancer Based on Nanoparticle Albumin-bound Paclitaxel and Gemcitabine: Circulating Tumor Cells as a Potential Biomarker for Treatment Monitoring, -Response and Survival
Study Start Date : November 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : January 2018


Arm Intervention/treatment
Experimental: Nab paclitaxel / gemcitabine
Patients will receive 125 mg per m2 nab-paclitaxel and 1000 mg per m2 on days 1, 8 and 15 followed by one week of rest before new treatment cycle.
Drug: Nab paclitaxel / gemcitabine
Patients will receive gemcitabine/nab-paclitaxel combination chemotherapy
Other Name: Nab-paclitaxel and Gemcitabine




Primary Outcome Measures :
  1. Change in levels of circulating tumor cells (CTCs) during treatment [ Time Frame: Baseline and 9 months ]

Secondary Outcome Measures :
  1. Post-baseline over-all survival [ Time Frame: Baseline and 9 months ]
  2. Post-baseline disease-specific survival [ Time Frame: Baseline and 9 months ]
  3. Post-baseline time to progression [ Time Frame: Baseline and 9 months ]
  4. Clinical response to treatment by RECIST 1.1 [ Time Frame: Baseline and 9 months ]
    Radiologic, clinical and biochemical assessment

  5. Changes in quality of life during treatment [ Time Frame: Baseline and 9 months ]
    Quality of Life is assessed every 4 weeks during treatment and then every 8th weeks.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female > 18 years up to 80 years
  • Histologically or cytologically proven adenocarcinoma of the pancreas before start of treatment. Also patients for whom there is a strong suspicion of unresectable pancreatic cancer will before the diagnosis is confirmed be asked for consent to take 2 additional biopsies at the time of diagnostic biopsy retrieval, in case the histological analysis confirms that they can be included.
  • Locally advanced (primarily unresectable) and/or metastatic disease.
  • Presence of at least one measurable lesion according to the RECIST criteria, not restricted to previously irradiated area or limited to bone, pleural effusion or ascites.
  • ECOG/WHO performance status ≤2
  • Absolute neutrophil count (ANC) >1.5 x 109 /L and platelet count >100 x 109/L
  • Total bilirubin < 1.5 times the upper limit of the normal range at the institution (ULN) or AST or ALT < 2 x ULN. If liver metastases are present, patients can be included if total bilirubin < 5× ULN or AST/ALT <10× ULN. Dose reductions of paclitaxel will be performed when bilirubin >2xULN, depending on increase of the bilirubin level according to the recommendations of the Summary of Product Characteristics.
  • Serum creatinin < 1,5 ULN / calculated creatine clearance > 60 ml/min.
  • Written informed consent

Exclusion Criteria:

  • Current infection, bowel obstruction or subobstruction, or other uncontrolled intercurrent illness.
  • Prior medical treatment for advanced pancreatic cancer
  • Confirmed brain metastasis.
  • Concurrent or past history of another malignancy except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix.
  • Treatment with any other investigational drug more than 30 days prior to study entry.
  • Allergy to anyone of the included drugs.
  • Female patient breast feeding or pregnancy
  • Not able/ or not willing to use adequate contraception (defined below). A pregnancy test will be included in the baseline visit for women of childbearing potential.

Information from the National Library of Medicine

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): NCT02707159


Contacts
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Contact: Bjørnar Gilje, MD, PhD 05151 ext +47 gibj@sus.no
Contact: Oddmund Nordgård, PhD 05151 ext +47 oddmundn@gmail.com

Locations
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Norway
Stavanger University Hospital Recruiting
Stavanger, Norway, 4068
Contact: Bjørnar Gilje, MD, PhD    05151 ext +47    gibj@sus.no   
Contact: Oddmund Nordgård, PhD    05151 ext +47    oddmundn@gmail.com   
Sponsors and Collaborators
Helse Stavanger HF
Investigators
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Principal Investigator: Bjørnar Gilje, MD, PhD Helse Stavanger HF

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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT02707159     History of Changes
Other Study ID Numbers: 2013/1743
2013-000633-13 ( EudraCT Number )
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016
Keywords provided by Helse Stavanger HF:
Circulating tumor cells
Nab-paclitaxel
Metastatic pancreatic cancer
Gemcitabine
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Neoplasm Metastasis
Neoplastic Cells, Circulating
Digestive System Diseases
Endocrine System Diseases
Neoplastic Processes
Pathologic Processes
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs