Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW 2992
Information source: Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Rash; Lung Cancer
Intervention: Tetracycline (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Instituto Nacional de Cancerologia de Mexico Official(s) and/or principal investigator(s): Oscar Arrieta, M.D., M.Sc., Principal Investigator, Affiliation: Instituto Nacional de Cancerología
Overall contact: Oscar Arrieta, M.D., M.Sc., Email: ogarrieta@gmail.com
Summary
1. Advanced NSCLC have a poor prognosis and the positive impact of chemotherapy is limited
by the development of intrinsic and acquired resistance.
2. Over the past decade, less toxic agents such as the innovative targeted therapies, i. e.
erlotinib or gefitinib, have the potential to improve the effectiveness and keep a good
quality of life with a low toxicity
3. BIBW 2992, an aniline-quinazoline, is an EGFR and HER-2 irreversible inhibitor, and it
has activity against erlotinib-resistant isoforms having mutations in EGFR and HER-2
4. This molecule have shown benefits as a single agent in pre-treated patients who have
progressed despite platinum-based chemotherapy, with a minimal toxicity compared to
chemotherapy
5. BIBW 2992 is associated with adverse effects similar to those for erlotinib and
gefitinib, such as rash and diarrhea. These symptoms can reduce the quality of life in
patients and lead to inconsistent EGFR inhibitor dose administration
6. There is no a standard treatment for rash, but case reports have tried to demonstrate
the benefit obtained with alcohol-free emollients, sunscreen with titanium dioxide or
antibiotic (topic or oral) treatment such as clindamycin or doxycycline,
anti-inflammatory drugs such as steroids and isotretinoin in the treatment of these
cutaneous injuries.
7. In order to reduce the incidence and severity of cutaneous toxicities, we will compare
the prophylactic antibiotic treatment using tetracycline and general dermatological
recommendations versus using only dermatological recommendations, in patients
initiating the treatment with BIBW 2992
Clinical Details
Official title: Phase II, Open-label, Single Blind, Randomised Clinical Trial With Tetracycline as a Prophylaxis for Rash and Dermatological Recommendations Versus Dermatological Recommendations in Patients With NSCLC Receiving Treatment With BIBW 2992
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Incidence and severity of rash
Secondary outcome: Quality of liferash and progression free-survival Rash and overall survival
Detailed description:
Case reports have tried to demonstrate the benefit obtained with alcohol-free emollients
used 2-3 times daily, sunscreen with titanium dioxide or zinc oxide with a SPF greater than
15, antibiotic (topic or oral) treatment (such as clindamycin, metronidazole, tetracyclines)
secondary to infection and steroidal anti-inflammatory drugs (betamethasone, triamcinolone)
and isotretinoin in the treatment of these cutaneous injuries.
The objective for this project is to evaluate whether prophylactic treatment with
tetracycline can reduce dermatological occurrences such as rash, induced by EGFR and HER-2
tyrosine kinase inhibitor BIBW 2992 in patients with non-small cell lung cancer, and improve
the patient's quality of life.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of non-operable, locally advanced, recurrent or metastatic, histologically
or cytologically documented non-small cell lung cancer (stage IIIB or IV).
- Patients should have an evidence of measurable disease.
- 18 years or older
- ECOG performance status 0-3
- At least 12 weeks of life expectancy
- Patients with non-small cell lung cancer stages IIIB/IV who have received at least
one cycle of platinum-based, first or second line systemic standard chemotherapy, and
have a documented failure for this treatment.
- More than 2 previous chemotherapy regimens are not allowed. The patients should have
recovered from any toxic effect and at least 2 weeks should have elapsed from last
dose before their entry (14 days for vinorelbine and other vinca alkaloids or
gemcitabine). Patients who in the investigator's opinion are fully recovered from
surgery for at least 4 weeks may also be considered for the study. Patients should
have recovered from any severe toxicity (CTC > 1) caused by any previous therapy.
- Granulocyte count > 1. 5x 109/L and platelet count > 100x 109/L.
- Serum bilirubin > 1. 5 upper limit normal (ULN)
- AST and/or ALT > 2 ULN (or >5 x ULN when clearly attributable to presence of hepatic
metastases).
- Serum creatinine > 1. 5 ULN or creatinine clearance < 60 mL/min
- Capability to fulfill the study and follow-up procedures.
- A negative pregnancy test should be obtained from all women of childbearing potential
within 72 hours previous to therapy beginning.
- Patients of reproductive potential should use effective contraceptive methods.
- Written (signed) informed consent to participate in the study
Exclusion Criteria:
- Patients allergic to the antibiotic therapy used.
- Any unsteady systemic disease (including active infection, hypertension grade
unsteady angina, congestive cardiac failure, hepatic, renal or metabolic disease).
- A previous treatment using a systemic anti-tumor therapy with EGFR inhibitors
(tyrosine kinase inhibitors).
- Any other malignant pathology within 5 previous years (except for carcinoma in situ
of cervix or basal-cell type skin cancer appropriately treated).
- Patients with cerebral metastases or spinal marrow compression recently diagnosed
and/or definitely surgery and/or radiation naïve-treatment patients are excluded.
Those with previously diagnosed and treated metastasis to CNS or spinal marrow
compression, having an evidence of steady disease (clinically steady in imaging
studies) are accepted for at least 2 months.
- Any significant ophthalmologic abnormality, especially severe dry-eye syndrome,
keratoconjunctivitis sicca, Sjögren's syndrome, severe exposure keratitis and any
other disorder that may increase the risk for corneal epithelial injure. Contact lens
use during the study is not recommended. The decision to continue to use contact lens
should be discussed with the oncologist responsible for patient treatment and the
ophthalmologist.
- Patients who cannot take oral medication, requiring intravenous nutrition, who
underwent previous surgical procedures affecting absorption, or with active peptic
ulcer.
- Nursing women.
Locations and Contacts
Oscar Arrieta, M.D., M.Sc., Email: ogarrieta@gmail.com
Instituto Nacional de Cancerología, México, D.F., Mexico city 14080, Mexico; Recruiting Oscar Arrieta, M.D., M.Sc., Email: ogarrieta@gmail.com Oscar Arrieta, M.D., M.Sc., Principal Investigator
Additional Information
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Starting date: December 2010
Last updated: January 15, 2014
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