Phase 1
Completed N=17
Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01302808 ↗Enrolled (actual)
17
Serious AEs
5.9%
Results posted
Jan 2021
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities and Maximum Tolerated Dose (MTD) — 0; 2; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities and Maximum Tolerated Dose (MTD) |
0; 2; 0; 0 | — |
| SECONDARY Area Under the Concentration-time Curve (AUC0 t) of Romidepsin in Combination With Erlotinib |
1207.00; 2185.52; 989.19; 1851.84 | — |
Eligibility Criteria
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 • Platelet count ≥100 x 109 cells/L
- Total bilirubin 480 milliseconds (msec);
- Major surgery or radiation within 2 weeks prior to study entry;
- Patients who are pregnant or breast-feeding;
- Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures;
- Prior exposure to romidepsin
Data sourced from ClinicalTrials.gov (NCT01302808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.