Clinical trial NCT02106884: Quality of Life in Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine and Nab-paclitaxel
Official title: Randomized Crossover Trial to Assess the Effects and Quality of Life in Patients With Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine in Combination With Nab-paclitaxel: QOLINPAC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
Locally advanced
Metastatic
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2014-04-08
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos)
timeFrame: From date of randomisation to 3, 6 and 12 months respectively
measure: QOL Global Health Status Deterioration-free Median Survival
timeFrame: From date of randomisation to end of follow up (max 3 years after database lock when applicable).
Secondary outcomes:
measure: Overall Response
timeFrame: Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).
measure: Duration of Response (in Responders)
timeFrame: Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).
measure: Disease Control
timeFrame: Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).
measure: Progression Free Survival
timeFrame: Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).
measure: Overall Survival
timeFrame: Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).
measure: Laboratory Safety Assessment
timeFrame: Measured during treatment, from signature of informed consent to end of treatment, plus 30 days mandatory safety follow-up period. Duration of treatment was variable for each patient.
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brugge
country: Belgium
facility: AZ St Lucas
city: Brussels
country: Belgium
facility: ULB Hôpital Erasme
city: Brussels
country: Belgium
facility: Cliniques Universitaires St Luc
city: Charleroi
country: Belgium
facility: CHU de Charleroi
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHC St Joseph
city: Liege
country: Belgium
facility: CHR Citadelle
city: Liege
country: Belgium
facility: CHU Sart-Tilman
city: Lier
country: Belgium
facility: Heilig Hartziekenhuis Lier
city: Mechelen
country: Belgium
facility: AZ Sint Maarten
city: Namur
country: Belgium
facility: Clinique St Elisabeth
city: Roeselare
country: Belgium
facility: AZ Delta
city: Turnhout
country: Belgium
facility: AZ Turnhout
Study officials:
affiliation: UZ Leuven
name: Eric Van Cutsem, MD
role: PRINCIPAL_INVESTIGATOR
References: