Status:
UNKNOWN
Capiri-sutent Phase-1 in Advanced Colo-rectal Cancer
Lead Sponsor:
Radboud University Medical Center
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this Phase 1 study is to identify the recommended dose of capiri and of sunitinib for combination therapy subsequent phase II trials.
Eligibility Criteria
Inclusion
- Histological proof of colorectal cancer
- Patients should have failed one previous line of systemic treatment for advanced disease (and not more than one treatment line), either with fluoropyrimidine monotherapy or in combination with oxaliplatin and/or bevacizumab.
- No prior treatment with irinotecan or sunitinib
- Age ≥ 18 years
- WHO PS 0-1 (see Appendix 3, corresponding with Karnofsky ≥ 70% )
- Life expectancy ≥ 12 weeks
- Written informed consent
Exclusion
- No measurable disease according to RECIST criteria.
- Prior anti-cancer therapy \< 3 weeks before first dose. For cetuximab \< 30 days or bevacizumab \< 60 days prior to the first dose.
- Unresolved toxicity \> CTC gr 1 from previous anti-cancer therapy (including radiotherapy) except for alopecia.
- Inadequate bone marrow function (Hb ≤ 5.6 mmol/L, absolute neutrophil count (ANC) ≤ 1.5 x 109/L, platelets ≤100 x 109/L)
- renal dysfunction (serum creatinine ≥ 1.5x ULN and glomerular filtration rate ≤ 50 ml/min)
- Prothrombin time (PT) and activated partial thromboplastin time (APTT) \> 2x ULRR
- Hepatic dysfunction (serum bilirubin ≥ 1.5x ULN, serum transaminases ≥ 2.5 x ULN)
- Greater than +1 proteinuria on two consecutive dipsticks taken no less then 2 weeks apart unless urinary protein \< 1,5 g in a 24 Hr period.
- Pregnant or lactating women
- History of clinical signs/symptoms of CNS metastases
- Previous intolerance of fluoropyrimidine therapy, known dihydropyrimidine dehydrogenase (DPD) deficiency. Known hypersensitivity to irinotecan or sunitinib of their excipients.
- No major surgery \< 4 weeks prior to study entry.
- No radiotherapy \< 4 weeks prior to study entry except for palliative radiotherapy at focal sites.
- Any evidence of concurrent severe or uncontrolled disease (i.e. uncontrolled hypertension, congestive heart failure, myocardial infarction \< 6 months, chronic active infection, poorly regulated diabetes mellitus)
- Any previous significant cardiovascular event during previous fluoropyrimidine therapy (i.e.
- myocardial ischemia or infarction, arterial thrombosis, pulmonary emboli)
- Mean Qtc with Bazetts correction \> 470 msec in screening ECG, or a history with familial long QT syndrome
- Significant haemorrhage (\>30 ml bleeding/episode in the last 3 months) or haemoptysis (\>5 ml fresh blood in previous 4 weeks)
- History of impairment of gastrointestinal function or -disease that may significantly impair the absorption of oral drugs (i.e. uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, bowel obstruction, or inability to swallow tablets)
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Concomitant use medication that may significantly affect hepatic cytochrome P450 drug metabolizing activity by way of enzyme induction or inhibition \< 2 weeks if the first dose and throughout the study period (see Appendix 2)
- Other concomitant anti-cancer therapy.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00777478
Start Date
December 1 2008
End Date
December 1 2012
Last Update
February 3 2012
Active Locations (1)
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1
University Medical Center Nijmegen st Radboud
Nijmegen, Gelderland, Netherlands, 6525 GH