E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chemotherapy Refractory Metastatic Colorectal Cancer |
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E.1.1.1 | Medical condition in easily understood language |
Cancer of the colon and rectum, which has spread to other organs. The patient has tried different types of chemotherapy with no effect. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052362 |
E.1.2 | Term | Metastatic colorectal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
• 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 (<2 years after last period for women) must use effective birth control.
• Signed Informed consent
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | 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. |
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E.5.2 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of last patient anticipated to be 31 March 2014 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |