Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT01302808
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Feb 24, 2011
Start date
Sep 30, 2009
Status verified
Jan 2021
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (Erlotinib plus Romidepsin (8 mg/m^2))
    Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
  • Experimental: Cohort 2 (Erlotinib plus Romidepsin (10 mg/m^2))
    Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
  • Experimental: Cohort 3 (Erlotinib plus Romidepsin (10 mg/m^2)) + Antiemetic prophylaxis
    Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
  • Experimental: Cohort 4 (Erlotinib plus Romidepsin (8 mg/m^2)) + Antiemetic prophylaxis
    Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities and Maximum Tolerated Dose (MTD) [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallasTexas75390-

Find similar trials in Dallas, TX

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas· Dallas, TX

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