Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Quality of Life Study in Patients With Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine in Combination With Nab-paclitaxel

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.


Eligibility: 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.

Relevance to patient case: not relevant