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A Phase I, Open-label Study to Determine the Effect of Panitumumab on the Pharmacokinetics of Irinotecan in Subjects With Unresectable Metastatic Colorectal Cancer


Phase 1
18 Years
75 Years
Not Enrolling
Both
Metastatic Colorectal Cancer

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Trial Information

A Phase I, Open-label Study to Determine the Effect of Panitumumab on the Pharmacokinetics of Irinotecan in Subjects With Unresectable Metastatic Colorectal Cancer


Inclusion Criteria:



- Pathologically confirmed unresectable mCRC which has progressed on at least one prior
5-fluorouracil (5FU)-containing chemotherapy regimen

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Life expectancy of >/= 3 months as documented by the investigator

- Baseline actual body weight
- Competent to comprehend, sign, and date a written IEC/IRB approved informed consent
form before any study-specific procedures are performed

Exclusion Criteria:

- Treatment with radiotherapy recovered from all radiotherapy-related toxicities

- Known presence of central nervous systems (CNS) metastases

- Any prior malignancy (except for non-melanomatous skin cancer or in situ cervical
cancer) other than the study disease, unless treated with curative intent with no
evidence of disease
- History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or
evidence of interstitial lung disease on baseline chest CT scan

- Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
(defined as > CTC grade 2 [CTCAE version 3])

- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia)
- UGT1A1*28 TA7/7, TA7/8, TA8/8 genetic polymorphisms; Gilbert's Disease

- Treatment with CYP3A4 enzyme inhibiting or inducing medications enrollment

- Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule
EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)

- Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved
proteins/antibodies (eg, bevacizumab)
- Subjects requiring immunosuppressive agents (eg, methotrexate and cyclosporine),
however corticosteroids are allowed

- Major surgery < 28 days prior to enrollment or minor surgery (excluding catheter
placement) < 14 days before enrollment

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Canada: Health Canada

Study ID:

20062010

NCT ID:

NCT00563316

Start Date:

January 2008

Completion Date:

March 2011

Related Keywords:

  • Metastatic Colorectal Cancer
  • colorectal cancer
  • chemotherapy
  • cancer
  • metastatic
  • irinotecan
  • EGFr
  • epidermal growth factor
  • Colorectal Neoplasms

Name

Location

Research SiteBillings, Montana  
Research SiteAsheville, North Carolina  
Research SiteAllentown, Pennsylvania  
Research SiteChattanooga, Tennessee