Lapatinib and Cetuximab in Patients With Solid Tumors (TYKERB-ITUX 1)
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|ClinicalTrials.gov Identifier: NCT01184482|
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : October 31, 2013
This trial is for patients with colon cancer, head and neck cancer and lung cancer that has not responded to standard therapy.
Cetuximab targets a receptor on cancer cells called the Epidermal Growth Factor Receptor or EGFR. It is thought that this receptor is turned "on" in some cancers, enabling cancer cells to divide and grow. Blocking this receptor can turn this signal off. Cetuximab blocks this receptor from the outside of cancer cells. It is thought that cancer cells can turn this signal back on by the EGFR joining with a related receptor called ErbB2. Lapatinib blocks both EGFR and ErbB2 from the inside of cancer cells. In laboratory experiments it has been found that combining drugs that target both EGFR and ErbB2 might work better in turning this signal back off. The purpose of this study is to determine the maximum dosages that patients can tolerate when these two medicines are given at the same time.
In addition, in order to be on this trial, patients must agree to have a tumor biopsy before starting treatment on this study and 21 days after starting treatment. These biopsies are a required part of the study. Patients must also agree to have blood drawn for research testing to see whether genetic differences between patients explain different reactions to and side effects from, these medicines.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Lung Cancer Head and Neck Cancer||Drug: cetuximab and lapatinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Lapatinib and Cetuximab in Patients With Solid Tumors|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||September 2013|
Experimental: Cetuximab and lapatinib
All patients will receive cetuximab by IB weekly and daily doses of lapatinib orally in 3 week cycles with response assessed every 2 cycles.
Drug: cetuximab and lapatinib
Cetuximab: 400 mg/m2 on Day 1 then 250 mg/m2 weekly
Lapatinib: Start once daily on Day 1. Dose escalating cohorts:
- Maximum tolerated dose [ Time Frame: 12 months ]The dose at which </= 1 out of 6 subjects experiences a dose limting toxicity
- response rate [ Time Frame: 12 months ]How well tumor responds to treatment as measured by RECIST criteria
- Pharmacokinetics [ Time Frame: 12 months ]Pharmacokinetics of lapatinib as measured by weekly trough levels
- Genetic polymorphisms [ Time Frame: 12 months ]genetic polymorphisms in ABCG2, ABCB1, CYP3A4, and CYP3A5 wil be identified and counted
- Genetic variations and activation status for EGFR and ErbB2 pathways [ Time Frame: 12 months ]Genetic variations and activation status for EGFR amd ErbB2 pathways will be measured in pre- and post-therapy biopsies and assessed with western blots and IHC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184482
|United States, District of Columbia|
|Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||John F Deeken, M.D.||Georgetown Univeristy Medical Center|