Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT00134069
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00134069
Study Brief:
Protocol Section:
NCT00134069