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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

Phase 2
18 Years
Open (Enrolling)
Skin Rash, Lung Cancer

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Trial Information

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

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.

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

- 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

- Patients who cannot take oral medication, requiring intravenous nutrition, who
underwent previous surgical procedures affecting absorption, or with active peptic

- Nursing women.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Incidence and severity of rash

Outcome Description:

From the day of initiation of BIBW 2992, we will register the incidence and grade of toxicity at baseline time, 2 weeks, 4 weeks and 8 weeks according to the CTCAE V4.0

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Oscar Arrieta, M.D., M.Sc.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto Nacional de Cancerología


Mexico: Ethics Committee

Study ID:




Start Date:

December 2010

Completion Date:

August 2013

Related Keywords:

  • Skin Rash
  • Lung Cancer
  • Lung cancer
  • BIBW 2992
  • Skin Rash
  • Tetracycline
  • Exanthema
  • Lung Neoplasms