Back to resultsCirculating Tumor Cells as Tools for Therapy Response in Nab-paclitaxel Treated Metastatic Pancreatic Cancer Patients (PACT-ACT-v6)
Primary Purpose
Metastatic Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Nab paclitaxel / gemcitabine
Sponsored by
About this trial
This is an interventional diagnostic trial for Metastatic Pancreatic Cancer focused on measuring Circulating tumor cells, Nab-paclitaxel, Metastatic pancreatic cancer, Gemcitabine
Eligibility 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.
Sites / Locations
- Stavanger University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nab paclitaxel / gemcitabine
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in levels of circulating tumor cells (CTCs) during treatment
Secondary Outcome Measures
Post-baseline over-all survival
Post-baseline disease-specific survival
Post-baseline time to progression
Clinical response to treatment by RECIST 1.1
Radiologic, clinical and biochemical assessment
Changes in quality of life during treatment
Quality of Life is assessed every 4 weeks during treatment and then every 8th weeks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02707159
Brief Title
Circulating Tumor Cells as Tools for Therapy Response in Nab-paclitaxel Treated Metastatic Pancreatic Cancer Patients
Acronym
PACT-ACT-v6
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
Keywords
Circulating tumor cells, Nab-paclitaxel, Metastatic pancreatic cancer, Gemcitabine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nab paclitaxel / gemcitabine
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Nab paclitaxel / gemcitabine
Other Intervention Name(s)
Nab-paclitaxel and Gemcitabine
Intervention Description
Patients will receive gemcitabine/nab-paclitaxel combination chemotherapy
Primary Outcome Measure Information:
Title
Change in levels of circulating tumor cells (CTCs) during treatment
Time Frame
Baseline and 9 months
Secondary Outcome Measure Information:
Title
Post-baseline over-all survival
Time Frame
Baseline and 9 months
Title
Post-baseline disease-specific survival
Time Frame
Baseline and 9 months
Title
Post-baseline time to progression
Time Frame
Baseline and 9 months
Title
Clinical response to treatment by RECIST 1.1
Description
Radiologic, clinical and biochemical assessment
Time Frame
Baseline and 9 months
Title
Changes in quality of life during treatment
Description
Quality of Life is assessed every 4 weeks during treatment and then every 8th weeks.
Time Frame
Baseline and 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjørnar Gilje, MD, PhD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stavanger University Hospital
City
Stavanger
ZIP/Postal Code
4068
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Circulating Tumor Cells as Tools for Therapy Response in Nab-paclitaxel Treated Metastatic Pancreatic Cancer Patients
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