Chemotherapy Refractory Metastatic Colorectal Cancer MedDRA version: 14.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: GEMCITABINE HYDROCHLORIDE
CAS Number: 122111-03-9
Pharmaceutical Form: Tablet
INN or Proposed INN: CAPECITABINE
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically verified colorectal adenocarcinomas • Age > 18 years • Metastatic colorectal cancer refractory to 5-FU, oxaliplatin, irinotecan and relevant biological agents. • Measurable disease according to RECIST 1.1 • ECOG performance status 0, 1 or 2 • Adequate renal, hepatic and haematological function • Consent to blood samples and available paraffin embedded tumour material for translational research studies • Fertile males and females (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Clinically significant concurrent disease. • Other malignant diseases within 5 years of inclusion in the study, except squamous cell carcinoma of the skin and cervical carcinoma-in-situ. • Other experimental therapy within 30 days of treatment initiation. • Patients who are breast feeding, childbearing or of childbearing potential without using dual effective contraception. • Clinical or radiological evidence of CNS metastasis. • Planned radiation therapy against target-lesions. • Known allergy to 5FU/capecitabine or gemcitabin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of the effect of combination treatment with capecitabine and gemcitabin for treatment resistant metastatic colorectal cancer reflected as the rate of patients with stable disease (defined as absence of progression after 3 months of treatment).;Secondary Objective: • To investigate progression free survival related to treatment with capecitabine og gemcitabin. • To investigate total survival related to treatment with capecitabine og gemcitabin • To investigate the tolerability of capecitabine and gemcitabin treatment • To indentify prognostic and predictive markers for treatment with capecitabine and gemcitabin. ;Primary end point(s): • The fraction of patients with absence of disease progression after 3 months of treament assessed by CT and/or MR scan and evaluated according to RECIST version 1.1.;Timepoint(s) of evaluation of this end point: After 3 months of treatment. If no sign of progression, continued evaluation every 3 months until progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Tolerabilitet: Kliniske og laboratoriemæssige AE (Adverse Events) vil blive graderet i henhold til NCI-CTCAE (version 4.0). • Progressionsfri overlevelse (PFS), defineret som tid beregnet fra dato for første behandlingsdag til først dokumenterede progression eller død uanset årsag. • Overall survival (OS), defineret som tid beregnet fra første behandlingsdag til død. • Translational research: Resultaterne af biomarkøranalyser sammenlignes med data for respons, PFS og OS samt korreleres til toksicitetsoplysninger og øvrige patient¬karakteristika. | — |
Countries
Denmark
Outcome results
None listed