Quality of life study in patients with pancreatic cancer receiving gemcitabine in combination with nab-paclitaxel or gemcitabine alone

Phase 1

• Conditions: locally advanced or metastatic pancreatic cancer; MedDRA version: 20.0 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004101-75-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-28
• Last Update Posted: 28 February 2019
• Study Completion: 2019-04-29

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 146

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 58
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85

Exclusion Criteria

1.Prior chemotherapy, 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.
2.Major surgery within 4 weeks of the start of the study.
3.Irradiation within 3 weeks prior to study entry.
4.Brain metastasis (known or suspected).
5.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.
6.Known infection with HIV or active infection with hepatitis B or C.
7.History of connective tissue disorders (eg. lupus, scleroderma, arteritis nodosa, etc).
8.History of interstitial lung disease.
9.History of peripheral artery disease.
10.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.
11.Known allergy or any other adverse reaction to any of the drugs or to any related compound.
12.Use of oral anticoagulants that interfere with the metabolic path of nab-Paclitaxel (cytochrome P450 isoenzymes CYP2C8 and CYP3A4) such as warfarin (Coumadin), rivaroxaban (Xarelto), etc, and the impossibility to switch anticoagulation treatment to low molecular weight heparin.
13.Organ allografts requiring immunosuppressive therapy.
14.Pregnancy or breast-feeding.
15.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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified