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Trial record 33 of 193 for:    Oral Cancer | ( Map: Mexico )

Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW2992 (Afatinib)

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ClinicalTrials.gov Identifier: NCT01880515
Recruitment Status : Completed
First Posted : June 19, 2013
Results First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Skin Rash
Lung Cancer
Intervention Drug: Tetracycline
Enrollment 107
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tetracycline No Tetracycline
Hide Arm/Group Description

Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)

Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW2992 (afatinib)

This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
Period Title: Overall Study
Started 53 54
Completed 45 45
Not Completed 8 9
Reason Not Completed
Lost to Follow-up             3             2
Disease Progression             5             7
Arm/Group Title Tetracycline No Tetracycline Total
Hide Arm/Group Description

Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations

Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992

This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur Total of all reporting groups
Overall Number of Baseline Participants 45 45 90
Hide Baseline Analysis Population Description
A total of 107 patients were enrolled. Due to progression and lost to follow-up, only 90 patients were evaluated for dermatological toxicities. Forty five patients were assigned to receive reactive treatment; the other 45 received pre-emptive tetracycline.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  26.7%
12
  26.7%
24
  26.7%
>=65 years
33
  73.3%
33
  73.3%
66
  73.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 45 participants 90 participants
57.5  (14) 56.6  (14) 57.05  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Female
33
  73.3%
33
  73.3%
66
  73.3%
Male
12
  26.7%
12
  26.7%
24
  26.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 45 participants 45 participants 90 participants
45 45 90
1.Primary Outcome
Title Frequency of Participants Who Experienced Any Grade of Rash As Characterized By The Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0
Hide Description Sum of participants who experienced any grade rash according to the Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0, from the initiation of BIBW2992 compared to week 8.
Time Frame Percentage of adverse events at week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Forty five patients were assigned to receive reactive treatment; the other 45 received pre-emptive tetracycline.There were no differences among demographics, disease stage and dermatological baseline characteristics between treatment groups.
Arm/Group Title Tetracycline No Tetracycline
Hide Arm/Group Description:

Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)

Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992

This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
Overall Number of Participants Analyzed 45 45
Measure Type: Number
Unit of Measure: Percentage of Patients w/any grade rash
44.5 75.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tetracycline, No Tetracycline
Comments Rash incidence of any grade, and grade ≥2 was less frequent in the pre-emptive arm versus the control arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value .4
Confidence Interval (2-Sided) 95%
0.17 to 0.99
Estimation Comments Rash incidence of any grade was less frequent in the pre-emptive arm versus the control arm.
2.Secondary Outcome
Title Quality of Life (QL)
Hide Description A QL questionnaire from European Organization for Research and Treatment of Cancer (EORTC) organization (spanish version) will be performed at initiation of BIBW 2992 and then every month of follow-up until progression
Time Frame from baseline to 6 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Progression Free-survival
Hide Description The measure will be from the start of consumption to the first documented evidence of progression according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or if patients still survive the measure will be made after 24 weeks
Time Frame 24 weeks from baseline
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Progression Free Survival
Hide Description From the start of consumption of BIBW 2992 to the date progression or last follow up
Time Frame Participants will be followed for the duration of the treatment, an average of 8 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
We estimated the progression free survival with the Kaplan Meier method, and comparisons among groups were performed with the log-rank test.
Arm/Group Title Tetracycline No Tetracycline
Hide Arm/Group Description:

Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)

Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW2992 whereas the non-intervention group will recieve general dermatological recomendations while on treatment with BIBW2992.

This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
Overall Number of Participants Analyzed 45 45
Median (95% Confidence Interval)
Unit of Measure: months
8.1
(1.7 to 14.3)
12.3
(7.1 to 17.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tetracycline, No Tetracycline
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame All patients were followed-up, every two weeks for skin toxicities by a dermatologist since the start of treatment with afatinib, until the fourth week.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tetracycline No Tetracycline
Hide Arm/Group Description

Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)

Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992

This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
All-Cause Mortality
Tetracycline No Tetracycline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tetracycline No Tetracycline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tetracycline No Tetracycline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Oscar Arrieta
Organization: Instituto Nacional de Cancerología
Phone: +52 55 56 28 04 00 ext 832
EMail: ogar@servidor.unam.mx
Publications:
C. Yang, J. Shih, W. Su, Et.Al. A phase II study of BIBW 2992 in patients with adenocarcinoma of the lung and activating EGFR mutations (LUX-Lung 2).- J Clin Oncol 28: 15s, 2010 (Suppl; Abstr 7521).
C. Yang, J. Shih, T. Chao, C. Tsai, Et.Al. Use of BIBW 2992, a novel irreversible EGFR/HER2 TKI, to induce regression in patients with adenocarcinoma of the lung and activating EGFR mutations: Preliminary results of a single-arm phase II clinical trial. J Clin Oncol 26: 2008
Gatzemeier U, Pluzanska A, Szczesna A, Kaukel E, Roubec, Brennscheidt U, De Rosa F, Mueller B, Von Pawel J: Results of a phase III trial of erlotinib (OSI-774) combined with cisplatin and gemcitabine (GC) chemotherapy in advanced non-small cell lung cancer (NSCLC) ASCO Annual Meeting 2004 abstract number 7010
Collen G., Vos L.E., Laurijsen A., Clasificación y tratamiento de los efectos secundarios de los inhibidorres del receptor de factor de crecimiento epidérmico (EGFR) en piel, pelo, uñas y mucosas. European Journal of Cancer. 2007, Vol 43: 845-851
Layout table for additonal information
Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT01880515     History of Changes
Other Study ID Numbers: TEPR-BIBW2992
First Submitted: May 31, 2013
First Posted: June 19, 2013
Results First Submitted: June 17, 2015
Results First Posted: April 12, 2017
Last Update Posted: April 12, 2017