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Status:

COMPLETED

Sorafenib, Cetuximab, and Irinotecan in Treating Patients With Advanced or Metastatic Colorectal Cancer

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Recurrent Colon Cancer

Recurrent Rectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

This phase I/II trial is studying the side effects and best dose of sorafenib when given together with cetuximab and irinotecan and to see how well they work in treating patients with advanced or meta...

Detailed Description

OBJECTIVES: I. Determine the toxicity spectrum and dose-limiting toxic effects of sorafenib when combined with cetuximab and irinotecan in patients with advanced or metastatic colorectal cancer. II....

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically or cytologically confirmed colorectal cancer (advanced or metastatic disease not amenable to potential curative resection)
  • Archival tumor (blocks and/or slides) must be available for patients who decline tumor biopsies
  • Tumor must be amenable to sequential biopsies for patients willing to undergo tumor biopsy
  • Must have evidence of disease progression after first-line chemotherapy for advanced disease
  • Previously irradiated lesions are not considered measurable disease
  • Measurable disease, defined as \>= 1 unidimensionally measurable target lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
  • No known brain metastases
  • Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100%
  • Life expectancy of more than 12 weeks
  • white blood cell count (WBC) \>= 3,000/mm\^3
  • Bilirubin normal
  • Creatinine normal OR creatinine clearance \>= 60 mL/min
  • No hypertension
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Able to swallow oral medication
  • Willing to undergo 2 sequential tumor and skin biopsies
  • No ongoing or active infection
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No prior cetuximab
  • No concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF) or epoetin alfa
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No other concurrent chemotherapy
  • More than 4 weeks since prior radiotherapy and recovered
  • No prior sorafenib
  • No other prior therapy targeted against MAPK
  • More than 14 days since prior and no concurrent administration of the following cytochrome P450 3A4 (CYP3A4) inducers:
  • Rifampin
  • Rifabutin
  • Hypericum perforatum (St. John's wort)
  • Phenytoin
  • Carbamazepine
  • Phenobarbital
  • More than 7 days since prior and no concurrent administration of the following CYP3A4 inhibitors:
  • Amiodarone
  • Clarithromycin
  • Diltiazem
  • Erythromycin
  • Grapefruit juice
  • Indinavir
  • Saquinavir
  • Lopinavir in combination with ritonavir
  • Fosamprenavir
  • Ritonavir
  • Atazanavir
  • Nelfinavir
  • Itraconazole
  • Ketoconazole
  • Nefazodone
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Absolute neutrophil count \>=1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • No evidence of bleeding diathesis
  • Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times upper limit of normal

Exclusion

    Key Trial Info

    Start Date :

    June 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2011

    Estimated Enrollment :

    48 Patients enrolled

    Trial Details

    Trial ID

    NCT00134069

    Start Date

    June 1 2005

    End Date

    December 1 2011

    Last Update

    April 16 2014

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of Colorado at Denver Health Sciences Center

    Aurora, Colorado, United States, 80045

    2

    Johns Hopkins University

    Baltimore, Maryland, United States, 21287-8936