Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 22, 2015
First Posted Date  ICMJE March 14, 2016
Last Update Posted Date March 14, 2016
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2016)
Change in levels of circulating tumor cells (CTCs) during treatment [ Time Frame: Baseline and 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2016)
  • Post-baseline over-all survival [ Time Frame: Baseline and 9 months ]
  • Post-baseline disease-specific survival [ Time Frame: Baseline and 9 months ]
  • Post-baseline time to progression [ Time Frame: Baseline and 9 months ]
  • Clinical response to treatment by RECIST 1.1 [ Time Frame: Baseline and 9 months ]
    Radiologic, clinical and biochemical assessment
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Circulating Tumor Cells as Tools for Therapy Response in Nab-paclitaxel Treated Metastatic Pancreatic Cancer Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Metastatic Pancreatic Cancer
Intervention  ICMJE Drug: Nab paclitaxel / gemcitabine
Patients will receive gemcitabine/nab-paclitaxel combination chemotherapy
Other Name: Nab-paclitaxel and Gemcitabine
Study Arms  ICMJE 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.
Intervention: Drug: Nab paclitaxel / gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 11, 2016)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02707159
Other Study ID Numbers  ICMJE 2013/1743
2013-000633-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helse Stavanger HF
Study Sponsor  ICMJE Helse Stavanger HF
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bjørnar Gilje, MD, PhD Helse Stavanger HF
PRS Account Helse Stavanger HF
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP