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

NCT02707159 | Completed Phase 2 DMC

• 2 other identifiers: 2013/17432013-000633-13
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Circulating tumor cells; Nab-paclitaxel; Metastatic pancreatic cancer; Gemcitabine

Outcome Measures

Primary Outcomes (1)

• Change in levels of circulating tumor cells (CTCs) during treatment

  Baseline and 9 months

Secondary Outcomes (5)

• Post-baseline over-all survival

  Baseline and 9 months

• Post-baseline disease-specific survival

  Baseline and 9 months

• Post-baseline time to progression

  Baseline and 9 months

• Clinical response to treatment by RECIST 1.1

  Baseline and 9 months

• Changes in quality of life during treatment

  Baseline and 9 months

Study Arms (1)

Nab paclitaxel / gemcitabine

EXPERIMENTAL

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

Interventions

Nab paclitaxel / gemcitabine DRUG

Patients will receive gemcitabine/nab-paclitaxel combination chemotherapy

Also known as: Nab-paclitaxel and Gemcitabine

Nab paclitaxel / gemcitabine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger University Hospital

Stavanger, 4068, Norway

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplastic Cells, Circulating

Interventions

Taxes; Gemcitabine; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bjørnar Gilje, MD, PhD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2015
• First Posted: March 14, 2016
• Study Start: November 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: January 1, 2019
• Last Updated: March 8, 2023

Record last verified: 2016-03

Locations

NO (1)