An Umbrella, Modular Study Based on Epidermal Growth Factor Receptor (EGFR) Mutation Status
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Umbrella Protocol for Histology-Independent, Phase I Modular Study Based on Epidermal Growth Factor Receptor (EGFR) Mutation Status: Using Erlotinib Alone or in Combination With Cetuximab, Bortezomib, or Dasatinib to Overcome Resistance|
- Maximum Tolerated Dose (MTD) and toxicity profiles via a brief initial "run-in"/dose escalation. [ Time Frame: Continous reassessment during dose level/cycles (28 days) ] [ Designated as safety issue: Yes ]MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle (induction phase). DLT defined as any Grade 3 or 4 non-hematologic toxicity as defined in the NCI CTC v3.0, even if expected and believed related to the study medications (except nausea and vomiting responsive to appropriate regimens or alopecia), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by the NCI-CTCAE), despite supportive care; any Grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity, including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in the NCI-CTCAE that is attributable to the therapy.
|Study Start Date:||May 2009|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Erlotinib Hydrochloride
Those eligible for umbrella of studies and have not received Erlotinib hydrochloride in past, will first receive Erlotinib hydrochloride alone.
Drug: Erlotinib Hydrochloride (Tarceva)
Dose of 150 mg daily by mouth.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903734
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Jennifer Wheler, MD||UT MD Anderson Cancer Center|