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Capiri-sutent Phase-1 in Advanced Colo-rectal Cancer

Information source: Radboud University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer

Intervention: capiri-sutent (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Radboud University

Official(s) and/or principal investigator(s):
C.M.L. van Herpen, MD, Phd, Principal Investigator, Affiliation: UMCN st Radboud

Overall contact:
C.M.L. van Herpen, Md, Phd, Phone: 0031 24 3610353, Email: c.vanherpen@onco.umcn.nl

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.

Clinical Details

Official title: A Phase I Dose Escalation Study With Sunitinib (SutentR) in Combination With Capecitabine and Irinotecan (Capiri) in Previously Treated Patients With Advanced Colorectal Cancer

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Tolerated Dose

Secondary outcome: determine the safety and toxicity profile using the CTCAE criteria.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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.

Locations and Contacts

C.M.L. van Herpen, Md, Phd, Phone: 0031 24 3610353, Email: c.vanherpen@onco.umcn.nl

University Medical Center Nijmegen st Radboud, Nijmegen, Gelderland 6525 GH, Netherlands; Recruiting
C.M.L van Herpen, Md, Phd, Principal Investigator
Additional Information

Starting date: December 2008
Last updated: February 2, 2012

Page last updated: August 23, 2015

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