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Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer (LUTRAERL)
This study is not yet open for participant recruitment.
Verified by British Columbia Cancer Agency, May 2007
First Received: May 10, 2007   No Changes Posted
Sponsors and Collaborators: British Columbia Cancer Agency
Hoffmann-La Roche
Information provided by: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00473083
  Purpose

The purpose of this trial is to determine if rash caused by erlotinib can be successfully treated and if so to determine the optimal treatment approach.

Hypothesis:

Hypothesis 1: If the incidence of rash is 50% while on erlotinib, prophylactic monotherapy with minocycline can prevent occurrence in 50% of these patients.

Hypothesis 2: Treatment of rash is successful in improving rash by at least one Grade in 80% of patients.

Hypothesis 3: In patients with untreated rash, the rash will be self-limiting in 25% of patients, and 65% will be grade 1, 2A, and 2b. Ten percent will be grade 3 requiring treatment with monotherapy intervention.


Condition Intervention Phase
Rash
Drug: minocycline; Lotion (clindamycin 2% /hydrocortisone 1%)
Phase II

MedlinePlus related topics: Cancer Lung Cancer Rashes
Drug Information available for: Hydrocortisone acetate Hydrocortisone Minocycline Minocycline hydrochloride Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Erlotinib hydrochloride Erlotinib Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized Controlled Trial of Systemic and Topical Treatments for Rash Secondary to Erlotinib in Advanced Stage IIIB or IV Non-Small Cell Lung Cancer

Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • Overall incidence of rash [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • To investigate if the rash caused by erlotinib is self-limiting [ Time Frame: 1 year ]

Estimated Enrollment: 150
Study Start Date: June 2007
Detailed Description:

Erlotinib has been shown to prolong survival in NSCLC patients who are no longer candidates for further chemotherapy. In July 2005, erlotinib was approved in Canada for the treatment of patients with locally advanced or metastatic NSCLC, following failure of first or second-line chemotherapy.

Erlotinib’s side effect profile includes rash. The incidence of rash in clinical trials has been reported to be approximately 50 - 75%, and has been hypothesised to parallel tumour response (20).

The treatment of rash is controversial and many oncologists believe it is untreatable and self-limiting. The cause of the rash is not well understood but is felt to be a systemic event. Clinical experience of the investigators has suggested that minocycline 100 mg orally given twice-daily for 4 weeks and clindamycin 2% and hydrocortisone 1% topical cream for moderate to severe rash is a successful treatment.

The objectives of this trial are to better delineate the rash and its features and to describe an optimal treatment. Since the rash is often facial in distribution and can therefore lead to physical and psychological distress to the patient, a dermatology life quality index will also be completed throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (stage IIIB or stage IV) non-small cell lung cancer.
  2. Evidence of disease (measurable disease is not mandatory).
  3. 18 years of age or older.
  4. ECOG performance status of 0 – 3.
  5. Written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Exclusion Criteria:

  1. A history of another cancer other than basal cell carcinoma or cervical cancer in situ within the past 3 years
  2. Prior therapy with any type of cancer growth factor inhibitor (EGFR inhibitor or agent targeting this family of growth factor receptors)
  3. Life expectancy of less than 12 weeks.
  4. Ongoing toxic effects from prior chemotherapy.
  5. Pregnant or lactating women.
  6. Females of childbearing potential who have a positive or no pregnancy test (pregnancy tests must be obtained within 72 hours before starting therapy). (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
  7. Male or female patients with reproductive potential who are unwilling to use effective and reliable contraceptive methods throughout the course of the study and for 90 days after the last dose of study medication.
  8. Ongoing treatment with any inhibitors or inducers of CYP3A4 activity
  9. Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
  10. Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions.
  11. Unwilling or unable to comply with the protocol for the duration of the study.
  12. Patients who have experienced prior hypersensitivity reaction to active ingredients or excipients of the following compounds: erlotinib, minocycline, tetracycline, doxycycline or clindamycin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473083

Contacts
Contact: Barb Melosky, MD 604 877-6000 ext 2742 bmelosky@bccancer.bc.ca

Locations
Canada, British Columbia
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
BC Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, Canada, V8R 6V5
BC Cancer Agency - Fraser Valley Centre
Vancouver, British Columbia, Canada, V3V 1Z2
Sponsors and Collaborators
British Columbia Cancer Agency
Hoffmann-La Roche
Investigators
Principal Investigator: Barb Melosky, MD BC Cancer Agency
  More Information

No publications provided

Study ID Numbers: ML21016
Study First Received: May 10, 2007
Last Updated: May 10, 2007
ClinicalTrials.gov Identifier: NCT00473083     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by British Columbia Cancer Agency:
Rash
Erlotinib
Lung Cancer

Study placed in the following topic categories:
Anti-Inflammatory Agents
Erlotinib
Thoracic Neoplasms
Clindamycin
Minocycline
Hydrocortisone
Skin Diseases
Clindamycin-2-phosphate
Cortisol succinate
Protein Kinase Inhibitors
Anti-Bacterial Agents
Exanthema
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Non-small Cell Lung Cancer
Hydrocortisone acetate
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Thoracic Neoplasms
Erlotinib
Anti-Infective Agents
Respiratory Tract Neoplasms
Clindamycin
Minocycline
Hydrocortisone
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Exanthema
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases

ClinicalTrials.gov processed this record on May 06, 2009