Trial record 6 of 105 for:    Open Studies | "Exanthema"

Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW 2992

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Instituto Nacional de Cancerologia de Mexico
Sponsor:
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier:
NCT01880515
First received: May 31, 2013
Last updated: January 15, 2014
Last verified: January 2014
  Purpose
  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

Condition Intervention Phase
Skin Rash
Lung Cancer
Drug: Tetracycline
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Cancerologia de Mexico:

Primary Outcome Measures:
  • Incidence and severity of rash [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    A QLQ questionnaire from EORTC organization (spanish version) will be performed at initiation of BIBW 2992 and then every month of follow-up until progression

  • rash and progression free-survival [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    The measure will be from the start of consumption to the first documented evidence of progression according to the RECIST criteria, or if patients still survive the measure will be made after 24 weeks

  • Rash and overall survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    From the start of consumption of BIBW 2992 to the date of death or last contact


Estimated Enrollment: 70
Study Start Date: December 2010
Estimated Study Completion Date: March 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tetracycline
Patients will receive tetracycline 250mg every 24 hrs for 1 month plus general dermatological recommendations (sunscreen and emollient cream)
Drug: Tetracycline
The experimental group will receive tetracycline 250mg every 24hrs for 1 month the same day at initiation of BIBW 2992
Other Name: Tetracycline
No Intervention: No Tetracycline
This arm only with general dermatologic recommendations. Patients in this arm can receive tetrayclines only if rash grade 3-4 occur during therapy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880515

Contacts
Contact: Oscar Arrieta, M.D., M.Sc. ogarrieta@gmail.com

Locations
Mexico
Instituto Nacional de Cancerología Recruiting
México, D.F., Mexico city, Mexico, 14080
Contact: Oscar Arrieta, M.D., M.Sc.       ogarrieta@gmail.com   
Principal Investigator: Oscar Arrieta, M.D., M.Sc.         
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Investigators
Principal Investigator: Oscar Arrieta, M.D., M.Sc. Instituto Nacional de Cancerología
  More Information

Publications:
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

Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, M.D., M.Sc., Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT01880515     History of Changes
Other Study ID Numbers: TEPR-BIBW2992
Study First Received: May 31, 2013
Last Updated: January 15, 2014
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Cancerologia de Mexico:
Lung cancer
BIBW 2992
Skin Rash
Tetracycline

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Dermatologic Agents
Tetracycline
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014