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

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

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.

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.