Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer
Condition: Rash
MeSH terms: Lung Neoplasms
Intervention: Minocycline; Clindamycin 2% in hydrocortisone 1% lotion; Erlotinib; Topical clindamycin 2%, triamcinolone acetonide 0.1% soln
Intervention description: Patients will receive prophylactic treatment with minocycline 100 mg orally twice-daily for at least 4 weeks on the initiation of erlotinib therapy. If rash occurs during the 4 week period of minocycline prophylaxis, the minocycline prophylaxis will continue and additional treatment by grade of rash will be according to the Treatment Arm 2 schedule. If rash occurs after the completion of the 4 week prophylaxis period, treatment by grade of rash will be according to the Treatment Arm 2 schedule.; Appropriate amounts of clindamycin and hydrocortisone powder are mixed with corresponding amount of Nutraderm® lotion for this mixture.
If preferred, the appropriate amount of clindamycin powder can be mixed with Emo-Cort® lotion (already contains hydrocortisone 1%), available in 60 mL bottles.; Erlotinib will be given on an outpatient basis at a fixed dose of either 150 or 100 mg as a single daily oral dose.; Clindamycin 2% in Triamcinolone acetonide 0.1% solution in equal parts propylene glycol and water
Intervention MeSH terms: Minocycline; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Hydrocortisone; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rash; Erlotinib; Lung Cancer

Summary:

      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.
    

Eligibility 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.