EUCTR2011-003052-40-GBActive, not recruitingPhase 1
An exploratory study to investigate the optimal scheduling of chemotherapy in patients with operable colorectal liver metastases - EPOC B
Southampton University Hospital NHS Trust0 sites78 target enrollmentStarted: August 16, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 78
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Confirmed colorectal adenocarcinoma: o either previous or current histologically confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of advanced and / or metastatic disease. o or radiologically confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of advanced and / or metastatic disease. Histological evidence of primary colorectal cancer should be sought wherever possible but liver metastases should not be biopsied. • Presence of potentially resectable colorectal cancer liver metastases without detectable extra-hepatic tumour that cannot be completely resected. The consulting surgeon and the radiologist, according to local practice, will determine resectability (see appendix VI for guideline). The following patients are eligible: o Patients with rectal cancer who would be suitable for short course radiotherapy as an adjuvant treatment. o Patients who have had long course chemoradiation and R0 surgery for rectal cancer o Patients with metachronous metastases having undergone complete resection of the primary tumour without gross or microscopic evidence of residual disease (R0). o Patients with synchronous metastases who have undergone R0-resection of the primary tumour more than one month before randomisation. o Patients with synchronous metastases for whom there is sufficient evidence (for example by CT scan or diagnostic laparoscopy) that both the primary tumour and the liver metastases can be completely resected during the same procedure and that resection of primary cancer can be delayed for 3 to 4 months. o Unidimensionally measurable disease (RECIST criteria, see appendix V) to measure pre-operative response. o Patients with previously resected liver metastases for whom surgery was performed = 1 year previously. • No previous systemic chemotherapy for metastatic disease o adjuvant chemotherapy with 5FU +/- FA, capecitabine or oxaliplatin may have been given, if completed > 6 months prior to trial entry. o rectal chemoradiotherapy may have been given, if completed > 1 month prior to trial entry. • ECOG performance status =2. • Patients who are considered by responsible consultant to be fit to undergo combination chemotherapy and surgery. • Baseline laboratory tests (within 1 week prior to randomisation): o neutrophils = 1.5 x10 to the power of 9/l and platelet count = 100 x10 to the power of 9/l o serum bilirubin = 1.25 x upper limit of normal (ULN), alkaline phosphatase = 5 x ULN, and serum transaminase (either AST or ALT) = 2.5 x ULN o estimated creatinine clearance (Cockcroft; appendix VIII) >50ml/min or measured GFR (EDTA clearance) >50 ml/min. • All patients must be aged 18 years or older. • For women of childbearing potential, negative pregnancy test and adequate contraceptive precautions. Adequate contraception for men. • Written informed consent. • Consent to allow surplus pathological material to be analysed for translational research projects (patients may decline participation in this supplementary component and still participate in the main trial).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- •Patients in whom there is an indication for chemotherapy to facilitate a R0 resection. • Patients in whom radio frequency ablation is felt to be an essential component of treatment. • Patients who are unfit for the chemotherapy regimens in this protocol or subsequent surgery, e.g.: o severe uncontrolled concurrent medical illness (including poorly-controlled angina or very recent MI, i.e. in previous 3 months) likely to interfere with protocol treatments. o Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication. o Partial or complete bowel obstruction. o Pre-existing neuropathy (> grade 1). • Patients requiring ongoing treatment with a contraindicated concomitant medication. • Patients with another previous or current malignant disease which, in the judgement of the treating investigator, is likely to interfere with EPOC B treatment or assessment of response. • Patients with known hypersensitivity reactions to any of the components of the study treatments. • Patients with a second metastatic site. • Female patients who are pregnant or lactating. • Patients with a personal or family history suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency or with known DPD deficiency. • Patients who are known to have tumours which are K-ras wild type. • Partial or complete bowel obstruction. • Chronic diarrhoea or inflammatory bowel disease. • Gilbert’s syndrome or other congenital abnormality of biliary transport (e.g. Crigler-Najjar syndrome, Dubin-Johnson syndrome). • Previous transplant surgery, requiring immunosuppressive therapy (due to interaction of cyclosporin-A with irinotecan). • Patients with = grade 1 residual neurotoxicity following oxaliplatin as adjuvant may be offered irinotecan and 5FU instead of oxaliplatin and fluoropyrimidine.
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