Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00903734
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 (cetuximab), Velcade (bortezomib), or Sprycel (dasatinib).
If the results of the screening portion of this clinical research study show that you are eligible to take part in one of the studies described above, the study drug that you will be assigned to take will depend on the results of biomarker analysis performed as a part of the screening tests described below. Biomarkers are chemical "markers" in the blood/tissue that may be related to how your body might react to the study drug.
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 before eating and 2 hours after eating. You will have study visits once a month. If you continue to be on study longer than 2 cycles, study visits may become less frequent.
At these visits, the following tests and procedures will be performed:
* Your performance status will be recorded.
* You will be asked to list any drugs you may be taking, including over-the-counter drugs.
* You will be asked about any symptoms you may have.
* You will have a physical exam, including measurement of your vital signs.
* Blood (about 2 teaspoons) will be collected for routine tests
After the first 8 weeks on study, you will have a CT or MRI scan to check the status of the disease. You will have a CT or MRI scan every 8 to 12 weeks after that.
You may continue taking Erlotinib hydrochloride for as long as you are benefitting. You will be taken off study if the disease gets worse or intolerable side effects occur. If the disease gets worse, the study doctor may assign you to 1 of 3 studies. The study doctor will discuss this in more detail with you.
Length of Study:
Your participation on this screening study will be over after all of the screening tests and procedures described above have been completed.
This is an investigational study. Up to 102 participants will take part in this study. All will be enrolled at MD Anderson.
Study:
NCT00903734
Study Brief:
Protocol Section:
NCT00903734