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

NCT00777478 | Unknown Phase 1 DMC

• 1 other identifier: UMCNONCO20083
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Sunitinib; Capecitabine; Irinotecan; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  after every completed doselevel

Secondary Outcomes (1)

• determine the safety and toxicity profile using the CTCAE criteria.

  after every completed doselevel

Interventions

capiri-sutent DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

University Medical Center Nijmegen st Radboud

Nijmegen, Gelderland, 6525 GH, Netherlands

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• C.M.L. van Herpen, MD, Phd

  UMCN st Radboud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

C.M.L. van Herpen, Md, Phd

CONTACT

0031 24 3610353; c.vanherpen@onco.umcn.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 3, 2012

Record last verified: 2012-01

Locations

NL (1)