Capiri-sutent Phase-1 in Advanced Colo-rectal Cancer (sutent-capiri)
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ClinicalTrials.gov Identifier: NCT00777478 |
Recruitment Status : Unknown
Verified January 2012 by Radboud University.
Recruitment status was: Recruiting
First Posted : October 22, 2008
Last Update Posted : February 3, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Drug: capiri-sutent | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | December 2008 |
Estimated Primary Completion Date : | May 2012 |
Estimated Study Completion Date : | December 2012 |

- Drug: capiri-sutent
A dose escalating study in a 3 + 3 design will be performed. At MTD dose 14 additional patients will be treated. First, the optimal dose of sunitinib in a continuous schedule will be determined, thereafter, further dose escalation of capecitabine and irinotecan will be investigated.
- Maximum Tolerated Dose [ Time Frame: after every completed doselevel ]
- determine the safety and toxicity profile using the CTCAE criteria. [ Time Frame: after every completed doselevel ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777478
Contact: C.M.L. van Herpen, Md, Phd | 0031 24 3610353 | c.vanherpen@onco.umcn.nl |
Netherlands | |
University Medical Center Nijmegen st Radboud | Recruiting |
Nijmegen, Gelderland, Netherlands, 6525 GH | |
Principal Investigator: C.M.L van Herpen, Md, Phd |
Principal Investigator: | C.M.L. van Herpen, MD, Phd | UMCN st Radboud |
Responsible Party: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00777478 |
Other Study ID Numbers: |
UMCNONCO20083 |
First Posted: | October 22, 2008 Key Record Dates |
Last Update Posted: | February 3, 2012 |
Last Verified: | January 2012 |
Sunitinib Capecitabine Irinotecan colorectal cancer |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Sunitinib Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |