Quality of Life in Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine and Nab-paclitaxel

NCT ID: NCT02106884

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2019-04-29

Brief Summary

This was a quality of life (QOL) study done in the context of a randomized trial in locally advanced or metastatic pancreatic cancer. Eligible patients were randomized to receive either the combination of nab-paclitaxel/gemcitabine or standard gemcitabine monotherapy. The combination regimen of nab-paclitaxel and gemcitabine showed improved efficacy with acceptable toxicity in this disease setting in first-line and was approved for this indication. The study design allowed patients in standard treatment to receive the combination treatment after first tumour progression.

The proposed study explored the impact of treatment on the QOL scores and compared the times to definitive deterioration of the QOL scores using the validated EORTC QLQ-C30 questionnaire. Efficacy and safety were secondary endpoints and were reported descriptively.

Molecular studies will be performed on blood and tissue samples as avaialble and will be reported separately.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Nab-paclitaxel - IV - 125 mg/m2 - 3xq4wks Gemcitabine - IV - 1000 mg/m2 - 3xq4wks

Group Type: EXPERIMENTAL

Nab-paclitaxel

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Arm B

Gemcitabine - IV - 1000 mg/m2 - 3xq4wks

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

Interventions

Nab-paclitaxel

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Other Intervention Names

Abraxane, EU/1/07/428/001, L01CD01; Gemzar

Eligibility Criteria

Inclusion Criteria

• Written informed consent (+ optional for TR) must be given according to ICH/GCP and national/local regulations.
• Patient is at least 18 years of age .
• Unresectable locally advanced or metastatic pancreatic cancer.
• Histologically or cytologically confirmed adenocarcinoma of the pancreas. Islet cell neoplasms are excluded.
• Evaluable or measurable disease, not in a previously irradiated area.
• Life expectancy of at least 12 weeks.
• WHO ECOG performance status ≤ 2
• Adequate organ function.
• Adequate bone marrow, hepatic and renal function. Acceptable coagulation (prothrombin time and partial thromboplastin time within +/- 15% of normal limits).
• No clinically significant abnormalities in urinalysis.
• Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.

Exclusion Criteria

• Prior chemotherapy, radiotherapy, surgery or other investigational therapy for the treatment for metastatic disease. Adjuvant treatment with gemcitabine or 5-FU is allowed provided at least 6 months have elapsed since completion of the last dose.
• Major surgery within 4 weeks of the start of the study.
• Irradiation within 3 weeks prior to study entry.
• Brain metastasis (known or suspected).
• Serious medical risk factors involving any of the major organ systems, including high cardiovascular risk including coronary stenting or myocardial infarction in the last year and psychiatric disorders.
• Historical or active infection with HIV, hepatitis B or C.
• History of connective tissue disorders (eg. lupus, scleroderma, arteritis nodosa, etc).
• History of interstitial lung disease.
• History of peripheral artery disease.
• Previous (within 5 years) or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and basal cell carcinoma of the skin.
• Known allergy or any other adverse reaction to any of the drugs or to any related compound.
• Use of Coumadin.
• Organ allografts requiring immunosuppressive therapy.
• Pregnancy or breast-feeding.
• Medical, social or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent.

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

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Van Cutsem, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

OLV Ziekenhuis Aalst

Aalst, , Belgium

AZ Klina

Brasschaat, , Belgium

AZ St Lucas

Bruges, , Belgium

ULB Hôpital Erasme

Brussels, , Belgium

Cliniques Universitaires St Luc

Brussels, , Belgium

CHU de Charleroi

Charleroi, , Belgium

UZ Antwerpen

Edegem, , Belgium

AZ Maria Middelares

Ghent, , Belgium

UZ Gent

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

Heilig Hartziekenhuis Lier

Lier, , Belgium

CHC St Joseph

Liège, , Belgium

CHR Citadelle

Liège, , Belgium

CHU Sart-Tilman

Liège, , Belgium

AZ Sint Maarten

Mechelen, , Belgium

Clinique St Elisabeth

Namur, , Belgium

AZ Delta

Roeselare, , Belgium

AZ Turnhout

Turnhout, , Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/8433390

The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.

http://www.ncbi.nlm.nih.gov/pubmed/25436122

Quality-of-life (QoL) as a predictive biomarker in patients with advanced pancreatic cancer (APC) receiving chemotherapy: results from a prospective multicenter phase 2 trial.

http://www.ncbi.nlm.nih.gov/pubmed/20724140

Time until definitive quality of life score deterioration as a means of longitudinal analysis for treatment trials in patients with metastatic pancreatic adenocarcinoma.

http://www.ncbi.nlm.nih.gov/pubmed/26185420

Pancreatic cancer: optimizing treatment options, new, and emerging targeted therapies.

http://www.ncbi.nlm.nih.gov/pubmed/18599286

Quality, interpretation and presentation of European Organisation for Research and Treatment of Cancer quality of life questionnaire core 30 data in randomised controlled trials

http://www.ncbi.nlm.nih.gov/pubmed/21561347

FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer

http://www.ncbi.nlm.nih.gov/pubmed/25638248

nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial.

http://www.ncbi.nlm.nih.gov/pubmed/23213101

Impact of FOLFIRINOX compared with gemcitabine on quality of life in patients with metastatic pancreatic cancer: results from the PRODIGE 4/ACCORD 11 randomized trial.

http://www.ncbi.nlm.nih.gov/pubmed/20886240

Minimal important differences for interpreting health-related quality of life scores from the EORTC QLQ-C30 in lung cancer patients participating in randomized controlled trials.

http://www.ncbi.nlm.nih.gov/pubmed/20030832

Quality of life data as prognostic indicators of survival in cancer patients: an overview of the literature from 1982 to 2008.

http://www.ncbi.nlm.nih.gov/pubmed/27914467

Impact of the occurrence of a response shift on the determination of the minimal important difference in a health-related quality of life score over time.

http://www.ncbi.nlm.nih.gov/pubmed/19695956

Baseline quality of life as a prognostic indicator of survival: a meta-analysis of individual patient data from EORTC clinical trials.

http://www.ncbi.nlm.nih.gov/pubmed/24127333

A global analysis of multitrial data investigating quality of life and symptoms as prognostic factors for survival in different tumor sites.

http://www.ncbi.nlm.nih.gov/pubmed/25207767

Pancreatic adenocarcinoma.

http://www.ncbi.nlm.nih.gov/pubmed/27247222

Metastatic Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline

http://www.ncbi.nlm.nih.gov/pubmed/28399388

Metastatic Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline Summary.Metastatic Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline Summary.

http://www.ncbi.nlm.nih.gov/pubmed/21969517

Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial.

http://www.ncbi.nlm.nih.gov/pubmed/24131140

Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine.

http://www.ncbi.nlm.nih.gov/pubmed/29791286

Metastatic Pancreatic Cancer: ASCO Clinical Practice Guideline Update.

http://www.ncbi.nlm.nih.gov/pubmed/25311306

Joint modeling of longitudinal health-related quality of life data and survival

http://www.ncbi.nlm.nih.gov/pubmed/24902940

Longitudinal quality of life data: a comparison of continuous and ordinal approaches

http://www.ncbi.nlm.nih.gov/pubmed/23341367

The role of the FOLFIRINOX regimen for advanced pancreatic cancer

Other Identifiers

2013-004101-75

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AX-CL-PANC-PI-003568

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

s56122

Identifier Type: -

Identifier Source: org_study_id