Status:
COMPLETED
An Umbrella, Modular Study Based on Epidermal Growth Factor Receptor (EGFR) Mutation Status
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Advanced Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this screening portion of this clinical research study is to learn if you are eligible to take part in a clinical research study using Tarceva (erlotinib hydrochloride) and either Erbitux ...
Detailed Description
Drug Administration and Study visits for Erlotinib hydrochloride: If you will be taking Erlotinib hydrochloride in this study, you will take Erlotinib hydrochloride by mouth daily at least 1 hour bef...
Eligibility Criteria
Inclusion
- Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have had no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
- Patients must have tumor tissue available, either from an archival specimen, or from a recent biopsy, to be analyzed for EGFR mutation. Patients must sign consent for the umbrella protocol prior testing for EGFR mutation. Patients will be eligible if they have an EGFR-sensitive mutation, OR if they have an EGFR-resistant mutation, OR if they do not have an EGFR mutation, but have benefited from EGFR inhibitor therapy (including either \>/= 4 months of stable disease \[SD\] OR a \>/= partial response \[PR\]).
- Measurable or non-measurable disease.
- Patients must be \>/= 6 wks beyond treatment with a nitrosourea or mitomycin-C, \>/= 4 wks beyond other chemotherapy or external beam radiation therapy (XRT), and must have recovered to \</= Grade 1 toxicity for any treatment-limiting toxicity resulting from prior therapy. (Exception: patients may have received palliative low dose XRT one week before treatment provided it is not given to the only targeted lesions).
- (continued from above) Also, patients who have received non-chemotherapeutic biological agents will need to wait at least 5 half-lives or 4 wks, whichever is shorter, from the last day of treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status \</= 2 (Karnofsky \>/= 60%)
- Patients must have normal organ and marrow function defined as: absolute neutrophil count \>/=1,000/mL; platelets \>/=50,000/mL; creatinine \</= 2 X upper limit of normal (ULN); total bilirubin \</= 2.0; ALT(SGPT) \</= 3 X ULN; Exception for patients with liver metastasis: total bilirubin \</= 3 x ULN; ALT(SGPT) \</= 5 X ULN.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients with uncontrolled concurrent illness, including but not limited to: ongoing or active infection; altered mental status or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results.
- Uncontrolled systemic vascular hypertension (systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg on medication).
- Patients with clinically significant cardiovascular disease: history of CVA within 6 months, myocardial infarction or unstable angina within 6 months, or unstable angina pectoris.
- Patients with colorectal carcinoma with tumors that demonstrate a Kirsten rat sarcoma (KRAS) mutation.
- Pregnant or lactating women
- Patients with a history of bone marrow transplant within the previous two years
- Patients with a known hypersensitivity to any of the components of the drug products.
- Patients who will be on treatment arm consisting of erlotinib and dasatinib should not be taking any drugs that are potent inhibitors or inducers of CYP34A
- Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs.
- Patients with major surgery within 30 days prior to entering the study.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00903734
Start Date
April 1 2009
Last Update
July 13 2015
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030