Quality of Life Study in Patients With Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine in Combination With Nab-paclitaxel
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
Pancreatic cancer, Locally advanced, Metastatic
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Abraxane (nab-paclitaxel) Type: Drug
Name: Gemcitabine Type: Drug
Overall Status
Recruiting
Summary
This is a quality of life study done in the context of a randomized trial in pancreatic cancer. Patients with locally advanced or metastatic pancreatic adenocarcinoma receive either the combination of nab-paclitaxel gemcitabine or the existing standard gemcitabine alone treatment.The combination regimen of nab-paclitaxel and gemcitabine administered in patients with locally advanced or metastatic pancreatic cancer in a first line setting showed improved efficacy with acceptable toxicity. The current study design allows patients in standard treatment to receive the combination treatment at tumour progression.

The proposed study will explore the impact of treatment on the quality of life and compare the times to definitive deterioration of the quality of life scores using the validated EORTC QLQ-C30. Efficacy and safety secondary endpoints are to be reported in a descriptive manner.

Molecular studies will be performed on blood and tissue samples.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Locations
OLV Ziekenhuis Aalst
Aalst, Belgium
Status: Recruiting
Contact: Koen Hendrickx, MD - koen.hendrickx@olvz-aalst.be
AZ Klina
Brasschaat, Belgium
Status: Not yet recruiting
Contact: Wim Demey, MD - wim.demey@klina.be
AZ St Lucas
Brugge, Belgium
Status: Recruiting
Contact: Joris Arts, MD - joris.arts@stlucas.be
Cliniques Universitaires St Luc
Brussels, Belgium
Status: Recruiting
Contact: Ivan Borbath, MD - ivan.borbath@uclouvain.be
ULB Hôpital Erasme
Brussels, Belgium
Status: Not yet recruiting
Contact: JL Van laethem, MD - jl.vanlaethem@erasme.ulb.ac.be
CHU de Charleroi
Charleroi, Belgium
Status: Recruiting
Contact: Brahim Ramdani, MD - brahim.ramdani@chu-charleroi.be
AZ Sint Blasius
Dendermonde, Belgium
Status: Not yet recruiting
Contact: David Van Brummelen, MD - david.vanbrummelen@azsintblasius.be
UZ Antwerpen
Edegem, Belgium
Status: Recruiting
Contact: Marc Peeters, MD - marc.peeters@uza.be
AZ Maria Middelares
Gent, Belgium
Status: Recruiting
Contact: Erik Vanderstraeten, MD - erik.vanderstraeten@azmmsj.be
UZ Gent
Gent, Belgium
Status: Recruiting
Contact: Stéphanie Laurent, MD - stephanielaurent@ugent.be
UZ Leuven
Leuven, Belgium
Status: Recruiting
Contact: Eric Van Cutsem, MD - 016/344218 - eric.vancutsem@uzleuven.be
CHC St Joseph
Liege, Belgium
Status: Recruiting
Contact: Ghislain Houbiers, MD - ghislain.houbiers@chc.be
CHR Citadelle
Liege, Belgium
Status: Recruiting
Contact: Bernard Delhougne, MD - bernard.delhougne@chrcitadelle.be
CHU Sart-Tilman
Liege, Belgium
Status: Recruiting
Contact: Daniel Van Daele, MD - Daniel.VanDaele@chu.ulg.ac.be
Heilig Hartziekenhuis Lier
Lier, Belgium
Status: Not yet recruiting
Contact: Leen Mortier, MD - leen.mortier@hhzhlier.be
AZ Sint Maarten
Mechelen, Belgium
Status: Recruiting
Contact: Michel Ferrante, MD - michel.ferrante@emmaus.be
Clinique St Elisabeth
Namur, Belgium
Status: Recruiting
Contact: Jean-Charles Goeminne, MD - jeancharlesgoeminne@cmsenamur.be
AZ Delta
Roeselare, Belgium
Status: Not yet recruiting
Contact: Jochen Decaestecker, MD - jochen.decaestecker@azdelta.be
AZ Turnhout
Turnhout, Belgium
Status: Recruiting
Contact: Jos Janssens, MD - jos.janssens@azturnhout.be
Start Date
April 2014
Completion Date
December 2016
Sponsors
Universitaire Ziekenhuizen Leuven
Source
Universitaire Ziekenhuizen Leuven
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page