A Phase I Dose Escalation Study of Erlotinib in Combination With Theophylline

Sponsor
AHS Cancer Control Alberta
Study ID
NCT02080078
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study is to determine the use of theophylline in patients with NSCLC and advanced solid malignancies and whether treatment with theophylline will help lower or diminish the side effect of diarrhea in patients taking erlotinib. Patients will be enrolled in one of two parts of the study to verify the lowest dose of theophylline that is effective and the highest dose of erlotinib that can be tolerated with theophylline. If this study shows that theophylline is able to inhibit erlotinib induced diarrhea, it will help demonstrate that patients using the tyrosine kinase inhibitor (TKIs), erlotinib, can use it effectively at higher doses without experiencing severe diarrhea.

Key Dates

First listed
Mar 6, 2014
Start date
Sep 30, 2014
Status verified
May 2019
Primary completion
Mar 30, 2019
Completion
Apr 30, 2019

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Increasing dose of Theophylline
    Patients will be put on the standard dose of 150 mg/day of erlotinib. Patients will be entered into the study on different dose levels of theophylline (100 mg/bid, 150 mg/bid, 200 mg/bid, or 200 mg/tid) for 28 days to find what is the lowest dose that effectively controls the diarrhea caused by erlotinib.
  • Experimental: Increasing dose of erlotinib
    Patients will be kept on a specified dose of theophylline while the dose of erlotinib increases in each group of patients enrolled (200 mg/qd, 225 mg/qd, or 250 mg/qd) for 28 days to determine what the maximum dose of erlotinib that can be given with theophylline and maintain a safety profile.

Primary Outcome Measure

The lowest effective dose of theophylline that will prevent or maximally ameliorate erlotinib's diarrhea at the standard dose of erlotinib at 150 mg/day taken daily for 28 days every 28 days [ Time Frame: 28 days ]

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