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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
147
100mg po daily
150mg po daily
Unnamed facility
Antibes, France
Unnamed facility
Bordeaux, France
Unnamed facility
Bordeaux, France
Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment
Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation.
Time frame: Days 0, 14, 28 and Months 2, 3, and 4
Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment
A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.
Time frame: Days 0, 14, 28 and Months 2, 3, and 4
Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type
A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.
Time frame: Days 0, 14, 28 and Months 2, 3, and 4
Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity
Intensity of skin rashes was classified according to CTCAE grading. Grade 1 equals (=) Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering less than (\<)50 percent (%) of body surface area (BSA); Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.
Time frame: Days 0, 14, 28 and Months 2, 3, and 4
Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment
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Unnamed facility
Brest, France
Unnamed facility
Caen, France
Unnamed facility
Chalon-sur-Saône, France
Unnamed facility
Chartres, France
Unnamed facility
Draguignan, France
Unnamed facility
Gap, France
Unnamed facility
Gleizé, France
...and 14 more locations
Time frame: Months 7, 10, and 12
Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment
A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.
Time frame: Months 7, 10, and 12
Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type
A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.
Time frame: Months 7, 10, and 12
Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity
Intensity of skin rashes was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering \<50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.
Time frame: Months 7, 10, and 12
Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event
Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.
Time frame: Days 0, 14, 28 and Months 2, 3, and 4
Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event
Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.
Time frame: Days 0, 14, 28 and Months 2, 3, and 4
Percentage of Participants Estimated to be Event Free at 4 Months
Percentage of participants estimated to be without skin rash (folliculitis) at 4 months.
Time frame: Days 0, 14, 28 and Months 2, 3, and 4
Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event
Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.
Time frame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event
Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.
Time frame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
Percentage of Participants Estimated to be Event Free at 12 Months
Percentage of participants estimated to be without skin rash (folliculitis) at 12 months.
Time frame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment
If the cutaneous rash was ongoing at the last visit or Month 4, the duration of cutaneous rash was calculated between start of folliculitis and Visit Month 4 or premature withdrawal visit or death.
Time frame: Days 0, 14, 28 and Months 2, 3, and 4
Duration of Skin Rash (Folliculitis) During the Whole Treatment Period
If the end of cutaneous rash was missing, the duration of cutaneous rash was calculated between start of folliculitis and last evaluation date.
Time frame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment
Other skin lesions included presence or absence of xerosis and paronychia.
Time frame: Days 0, 14, 28 and Months 2, 3, and 4
Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type
Other skin lesions included xerosis and paronychia.
Time frame: Days 0, 14, 28 and Months 2, 3, and 4
Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity
Other skin lesions included xerosis and paronychia. Intensity was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering \<50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation; Grade 4=Generalized exfoliative, ulcerative, or bullous dermatitis. If a participant had several skin lesions, the maximal intensity was taken into account.
Time frame: Days 0, 14, 28 and Months 2, 3, and 4
Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction
Erlotinib dose adjustment was done in case of toxicity occurrence. Keratitis, diarrhea, interstitial lung disease, and other toxic occurrences determined erlotinib dose reduction. If erlotinib was previously discontinued for skin rash or diarrhea of Grade 2 and if these symptoms of Grade 2 recurred OR if the symptoms were intolerable for the participants, erlotinib was discontinued until recovery/Grade 1 then the dose was reduced of one level of 50 mg.
Time frame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction
Occurrence of folliculitis-type skin rash of Grade greater than or equal to (≥)2 led to dose modification. Continuation of treatment with doxycycline after occurrence of folliculitis-type skin rash of Grade ≥2 was upon the investigator's opinion.
Time frame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
Percentage of Participants With Global Disease Control by Visit
Disease control was determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation and was defined as participants with either complete response (CR), partial response (PR), or stable disease (SD).
Time frame: Months 2, 4, 7, 10, and 12
Percentage of Participants by Best Global Response Under Treatment
Response was determined according to the RECIST criteria for evaluation and was defined as participants with either CR, PR, SD, or progression. No CR was reported.
Time frame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
Progression-Free Survival (PFS) - Percentage of Participants With an Event
PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.
Time frame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
Progression-Free Survival (PFS) - Time to Event
PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.
Time frame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
Percentage of Participants Estimated to be Progression Free at 4 and 12 Months
Time frame: Months 4 and 12
Overall Survival (OS) - Percentage of Participants With an Event
OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.
Time frame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
Overall Survival (OS) - Time to Event
OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.
Time frame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
Percentage of Participants Estimated to be Alive at 4 and 12 Months
Time frame: Months 4 and 12
Dermatology Life Quality Index (DLQI) Global Score
Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. Analysis was performed by visit well as at the last available value after baseline (Endpoint); change from baseline to endpoint was also determined.
Time frame: Baseline, Days 14 and 28 and Months 2, 3, and 4
Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life
Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. The DLQI global score was classified into 5 levels: 0-1 (no effect at all), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect) and 21-30 (extremely large effect).
Time frame: Baseline, Days 14 and 28 and Months 2, 3, and 4
Quality of Life Score as Assessed by Visual Analog Scale (VAS)
Quality of life was assessed by participant's responses to a VAS questionnaire - (evaluation of satisfaction with skin status). VAS was measured on a 100 millimeter (mm) scale where 0 = not at all satisfied and 100 = very satisfied. Participants were asked to mark the line corresponding to their satisfaction at each visit and the distance from the left edge was measured. A negative change from baseline indicates improvement. Analysis was performed by visit well as at the last available value after baseline (Endpoint).
Time frame: Baseline, Days 14 and 28, and Months 2, 3, and 4