Circulating Tumor Cells as Tools for Therapy Response in Nab-paclitaxel Treated Metastatic Pancreatic Cancer Patients

NCT ID: NCT02707159

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2019-01-31

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.

Conditions

Metastatic Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nab paclitaxel / gemcitabine

Intervention Type: DRUG

Patients will receive gemcitabine/nab-paclitaxel combination chemotherapy

Interventions

Nab paclitaxel / gemcitabine

Patients will receive gemcitabine/nab-paclitaxel combination chemotherapy

Intervention Type: DRUG

Other Intervention Names

Nab-paclitaxel and 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bjørnar Gilje, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Locations

Stavanger University Hospital

Stavanger, , Norway

Countries

Norway

Other Identifiers

2013-000633-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2013/1743

Identifier Type: -

Identifier Source: org_study_id