A Phase 2 interventional study of erlotinib in Carcinoma, Non-Small-Cell Lung, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-26.
Sponsored by Ohio State University Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
This study determines tumor response rate, time to tumor progression and survival rate at 1 year produced by OSI-774 in previously treated African American patients with nonsmall cell lung cancer.
Rationale: Researchers are seeking to identify treatment regimens with low toxicity for non-small cell lung cancer (NSCLC), especially for African Americans with this disease who seem to have a larger burden of comorbidities and decreased performance status. The current study uses a drug called OSI-774 in previously treated African American patients with NSCLC. OSI-774 is a targeted agent designed as an EGFR tyrosine kinase inhibitor. Previous research indicates that tumor cells overexpress EGFR receptors, and this drug works by blocking these receptors on tumor cells that that help them grow.
OSI-774 is FDA approved for the treatment of patients with non-small cell lung cancer that had been previously treated with chemotherapy. Unfortunately, very little data exist in the pharmacokinetics and metabolism of EGFR blockers in African Americans and in the assessment of how efficacious these agents are in this patient group. Yet, research suggests that EGFR blockage may have a greater impact on this patient population. Since the development of skin rash following therapy with EGFR blockers may be a surrogate of obtaining sufficient concentrations at the tissue level and potential efficacy, the current study is a randomized phase II trial designed to compare normal dose levels of OSI-774 with dose levels determined by body weight and with subsequent amounts adjusted further into the study to generate a skin rash. Through the current study, researchers are testing their theory that this dosing method will increase the number of patients with effective tissue concentrations and result in an increase in patient responses.
Purpose: The primary objective of this study is to determine the objective tumor response rate, the time to tumor progression, and the survival rate at one year produced by OSI-774 in previously treated African American patients with advanced NSCLC. A second objective is to evaluate if a regimen of single agent OSI-774, with dosing initially influenced by body weight and with subsequent titration to achieve skin rash is a suitable regimen for future studies of this agent. A third objective is to measure if changes in EGFR from tumor and blood cells correlate with the development of rash and clinical benefit. The pharmacokinetics of OSI-774 will also be characterized through study participants.
Treatment: Patients in this study will be given OSI-774. A computer will randomly assign patients into one of two treatment groups. Group one will be given a standard dose of OSI-774. The dose of OSI-774 will not be increased in group one. However, patients in group one will have the dose level decreased due to unacceptable side effects. Group two will receive OSI-774 at a dose modified to their body weight at study entry and subsequently adjusted further into the study to generate a skin rash. For all study participants, OSI-774 will be administered daily in oral pills. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 57 is close to the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
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Exclusion Criteria:
erlotinib 150 mg/day cycles 1 - 3
Drug: erlotinib
erlotinib Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to skin rash.
Drug: erlotinib
Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.
Also known as: Tarceva
Disease Control Rate at 12 Weeks
no progression of disease at 12 weeks from starting treatment
Time frame: 12 weeks
Time to Progression
Time frame: Every 12 weeks
1-year Survival Rate
Time frame: 12 months
| Milestone | Arm A: Erlotinib 150 mg/Day | Arm B: Erlotinib 150 to 200 mg/Day Depending on Body Weight; C |
|---|---|---|
| Started | 30 | 28 |
| Completed | 28 | 27 |
| Not completed | 2 | 1 |
no progression of disease at 12 weeks from starting treatment
| participants | Erlotinib: Arm A: 150 mg/Day Cycles 1 - 3. | Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C |
|---|---|---|
| Disease Control Rate at 12 Weeks | 6 | 6 |
| months | A Erlotinib 150 mg/Day Cycles 1 - 3 | B Erlotinib Cycle 1 Dose Modified According to Weight |
|---|---|---|
| Time to Progression | 2.8 (2.5 to 3.1) | 2.4 (1.5 to 2.7) |
| percentage of patients | A Erlotinib 150 mg/Day Cycles 1 - 3 | B Erlotinib Cycle 1 Dose Modified According to Weight |
|---|---|---|
| 1-year Survival Rate | 30 | 26 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: 150 mg/Day Cycles 1 - 3 | — | 1/28 (3.6%) | 19/28 (67.9%) |
| Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C | — | 0/27 (0%) | 19/27 (70.4%) |
| Event | Arm A: 150 mg/Day Cycles 1 - 3 | Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C |
|---|---|---|
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/28 | 0/27 |
| Event | Arm A: 150 mg/Day Cycles 1 - 3 | Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C |
|---|---|---|
| rashSkin and subcutaneous tissue disorders | 19/28 | 19/27 |
| diarrheaGastrointestinal disorders | 9/28 | 7/27 |
| anorexiaGastrointestinal disorders | 9/28 | 7/27 |
| Nausea/vomittingGastrointestinal disorders | 2/28 | 6/27 |
Fifty-eight patients . 31 men, 24 women.
| Age, Continuous(years) | Arm A: 150 mg/Day | Arm B: Cycle 1 - 150-200 mg/Day Depending on Body Weight | Total |
|---|---|---|---|
| Median | 63 (29 to 83) | 59 (37 to 96) | 62 (29 to 96) |
| Sex: Female, Male(Participants) | Arm A: 150 mg/Day | Arm B: Cycle 1 - 150-200 mg/Day Depending on Body Weight | Total |
|---|---|---|---|
| Female | 11 | 13 | 24 |
| Male | 17 | 14 | 31 |
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Ohio State University Comprehensive Cancer Center