Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small … (NCT01302808) | Clinical Trial Compass
CompletedPhase 1
Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
United States17 participantsStarted 2009-09
Plain-language summary
RATIONALE: Romidepsin and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of romidepsin when given together with erlotinib hydrochloride and to see how well they work in treating patients with stage III or stage IV non-small cell lung cancer.
Who can participate
Age range18 Years
SexALL
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To be eligible for study participation, patients must fulfill all of the following criteria:
* Histologically confirmed locally advanced or metastatic (stage IIIB pleural effusion or stage IV) NSCLC;
* Age ≥ 18 years;
* Written informed consent;
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST);
* ECOG (Eastern Cooperative Oncology Group ) performance status 0 to 1;
* Serum potassium and magnesium greater than or equal to the lower limit of institutional normal range (electrolyte abnormalities may be corrected with supplementation to meet inclusion criteria);
* Negative urine or serum pregnancy test on females of childbearing potential;
* All women of childbearing potential must use an effective barrier method of contraception (an intrauterine contraceptive device \[IUCD\] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male patients should use a barrier method of contraception during the treatment period and for at least 1 month thereafter. Hormonal methods of contraception such as the contraceptive pill or patch (particularly those containing ethinyl-estradiol) should be avoided due to a potential drug interaction (see Appendix D).
* Adequate bone marrow, liver, and renal function as evidenced by
* Hemoglobin ≥10 g/dL (transfusions and/or erythropoietin-stimulating agents are permitted)
* Absolute neutrophil count (ANC) ≥1.5 x 109 cells/L • Platele…
What they're measuring
1
Number of Participants With Dose Limiting Toxicities and Maximum Tolerated Dose (MTD)
Timeframe: 12 months
Trial details
NCT IDNCT01302808
SponsorUniversity of Texas Southwestern Medical Center