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Capiri-sutent Phase-1 in Advanced Colo-rectal Cancer (sutent-capiri)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: capiri-sutent Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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.

Outcome Measures

Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: after every completed doselevel ]

Secondary Outcome Measures :
  1. determine the safety and toxicity profile using the CTCAE criteria. [ Time Frame: after every completed doselevel ]

Eligibility Criteria

Information from the National Library of Medicine

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

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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


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

Locations
Netherlands
University Medical Center Nijmegen st Radboud Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GH
Principal Investigator: C.M.L van Herpen, Md, Phd         
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: C.M.L. van Herpen, MD, Phd UMCN st Radboud
More Information

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00777478     History of Changes
Other Study ID Numbers: UMCNONCO20083
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: January 2012

Keywords provided by Radboud University:
Sunitinib
Capecitabine
Irinotecan
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Irinotecan
Sunitinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors