Phase 2
N=147
A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00531934 ↗Enrolled (actual)
147
Serious AEs
28.6%
Results posted
Aug 2014
Primary outcome: Primary: Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment — 71.2; 80.8 percentage of participants — p=0.175
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Doxycline (Drug); erlotinib [Tarceva] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment |
71.2; 80.8 | 0.175 |
| SECONDARY Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment |
57; 62 | — |
| SECONDARY Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type |
55.8; 70.7; 65.4; 72.4; 1.9; 0 | — |
| SECONDARY Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity |
61.5; 18.6; 34.6; 62.7; 3.8; 18.6 | <0.001 sig |
| SECONDARY Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment |
2.7; 1.4 | — |
| SECONDARY Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment |
2; 1 | — |
| SECONDARY Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type |
1; 1; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity |
2; 1; 2; 1 | — |
| SECONDARY Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event |
52; 59 | — |
| SECONDARY Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event |
14; 13 | 0.143 |
| SECONDARY Percentage of Participants Estimated to be Event Free at 4 Months |
24.7; 11.2 | — |
| SECONDARY Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event |
53; 59 | — |
| SECONDARY Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event |
14; 13 | 0.153 |
| SECONDARY Percentage of Participants Estimated to be Event Free at 12 Months |
19.8; 11.2 | — |
| SECONDARY Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment |
59.6; 60.6 | — |
| SECONDARY Duration of Skin Rash (Folliculitis) During the Whole Treatment Period |
86.7; 99.3 | — |
| SECONDARY Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment |
39.7; 42.5 | — |
| SECONDARY Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type |
37.0; 41.1; 6.8; 8.2 | — |
| SECONDARY Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity |
69.0; 29.0; 24.1; 51.6; 6.9; 16.1 | 0.003 sig |
| SECONDARY Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction |
80.0; 85.7; 0; 2.4; 20.0; 11.9 | — |
| SECONDARY Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction |
50.0; 50.0 | — |
| SECONDARY Percentage of Participants With Global Disease Control by Visit |
88.2; 93.9; 89.5; 80.0; 72.7; 76.5 | — |
| SECONDARY Percentage of Participants by Best Global Response Under Treatment |
15.5; 10.3; 36.2; 48.3; 48.3; 41.4 | — |
| SECONDARY Progression-Free Survival (PFS) - Percentage of Participants With an Event |
91.8; 87.8 | — |
| SECONDARY Progression-Free Survival (PFS) - Time to Event |
63.0; 70.0 | — |
| SECONDARY Percentage of Participants Estimated to be Progression Free at 4 and 12 Months |
30.1; 31.0; 6.3; 10.8 | — |
| SECONDARY Overall Survival (OS) - Percentage of Participants With an Event |
71.2; 67.6 | — |
| SECONDARY Overall Survival (OS) - Time to Event |
227.0; 251.0 | — |
| SECONDARY Percentage of Participants Estimated to be Alive at 4 and 12 Months |
68.5; 69.7; 27.1; 33.5 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) Global Score |
0.2; 0.2; 1.7; 3.7; 1.7; 3.4 | — |
| SECONDARY Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life |
98.5; 97.1; 1.5; 2.9; 69.8; 41.9 | — |
| SECONDARY Quality of Life Score as Assessed by Visual Analog Scale (VAS) |
81.4; 87.8; 68.8; 51.0; -16.2; -39.2 | — |
Summary
This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, 18-75 years of age;
- confirmed non-small cell lung cancer;
- failure after first line chemotherapy for advanced disease, and scheduled for second line therapy with Tarceva.
Exclusion Criteria
- rash of any etiology at study entry;
- history of significant heart disease;
- any other malignancies (other than adequately treated squamous cell skin cancer, or in situ cancer of the cervix);
- history of allergic reactions to tetracyclines.
Data sourced from ClinicalTrials.gov (NCT00531934). 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.