Erlotinib in Combination With Cetuximab
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: May 6, 2009
Last updated: March 5, 2013
Last verified: March 2013
The goal of this clinical research study is to find the highest tolerable dose of Tarceva (erlotinib hydrochloride) that can safely be given in combination with Erbitux (cetuximab). The safety of this drug combination will also be studied.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I Dose-Escalation Study of Erlotinib in Combination With Cetuximab in Subjects With Advanced Cancer. Companion Study to Umbrella Protocol 2007-0638.
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||April 2014 (Final data collection date for primary outcome measure)
Experimental: Erlotinib + Cetuximab
Erlotinib in Combination with Cetuximab
Starting dose 100 mg by mouth 1 time every day for 28-day cycle (Pediatric starting dose 50 mg).
- Erlotinib Hyrdrochloride
Loading dose of 200 mg/m^2 (maintenance 125 mg/m^2) by vein 1 day every week of 28-day cycle, on Days 1, 8, 15 and 22. First dose given over 2 hours and over 1 hour each subsequent time.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Measurable or non-measurable disease.
- Patients must be >/= 6 wks beyond treatment with a nitrosourea or mitomycin-C, >/= 4 wks beyond other chemotherapy or 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.
- 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 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
- For the MTD expansion cohort, patients will be eligible if they meet one of the following criteria: (I) Have an EGFR-sensitive mutation and have been previously treated with EGFR inhibitor therapy but have subsequently developed resistance, OR (II) Have an EGFR-resistant mutation, OR (III) 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]).
- 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 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895362
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Jennifer J. Wheler, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 6, 2009
||March 5, 2013
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action