Digi-Panc-1; A prospective single-arm pilot phase II trial of digitoxin in combination with chemotherapy for patients with inoperable pancreatic cancer

Conditions

Pancreatic cancer

Brief summary

Progression free survival at 1 year; from the date of enrollment, i.e. from start to take digitoxin tablets.

Detailed description

Overall survival at 1 year., Progression-free survival defined as the time from enrollment until the earliest date of disease progression determined by assessment of objective radiographic disease per RECIST (v1.1)., Objective response rate and duration of response determined by radiographic disease assessments per RECIST (v1.1)., Safety and tolerability of the treatment regimens by assessment of adverse events and changes in safety assessments including laboratory parameters., Biochemical response: change in serum tumor markers (CA19-9, CEA, CA125) before start of digitoxin tablets as baseline and at every 3 months evaluation., Quality of Life according to EORTC QLQ-C30 and EORTC QLQ-PAN-26., Translational studies: Cytokines pivotal for cancer and inflammation will be analyzed. More than 40 cytokines will be examined before start of digitoxin and at 3 months of treatment with digitoxin.

Related papers

No related papers found yet.

Interventions

DRUGDigitoxin AWD 0

DRUG07 0

DRUG07 mg/Tablette

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression free survival at 1 year; from the date of enrollment, i.e. from start to take digitoxin tablets.	—

Secondary

Measure	Time frame
Overall survival at 1 year., Progression-free survival defined as the time from enrollment until the earliest date of disease progression determined by assessment of objective radiographic disease per RECIST (v1.1)., Objective response rate and duration of response determined by radiographic disease assessments per RECIST (v1.1)., Safety and tolerability of the treatment regimens by assessment of adverse events and changes in safety assessments including laboratory parameters., Biochemical response: change in serum tumor markers (CA19-9, CEA, CA125) before start of digitoxin tablets as baseline and at every 3 months evaluation., Quality of Life according to EORTC QLQ-C30 and EORTC QLQ-PAN-26., Translational studies: Cytokines pivotal for cancer and inflammation will be analyzed. More than 40 cytokines will be examined before start of digitoxin and at 3 months of treatment with digitoxin.	—

Measure

Time frame

Overall survival at 1 year., Progression-free survival defined as the time from enrollment until the earliest date of disease progression determined by assessment of objective radiographic disease per RECIST (v1.1)., Objective response rate and duration of response determined by radiographic disease assessments per RECIST (v1.1)., Safety and tolerability of the treatment regimens by assessment of adverse events and changes in safety assessments including laboratory parameters., Biochemical response: change in serum tumor markers (CA19-9, CEA, CA125) before start of digitoxin tablets as baseline and at every 3 months evaluation., Quality of Life according to EORTC QLQ-C30 and EORTC QLQ-PAN-26., Translational studies: Cytokines pivotal for cancer and inflammation will be analyzed. More than 40 cytokines will be examined before start of digitoxin and at 3 months of treatment with digitoxin.

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Countries

Sweden

Outcome results

None listed