Ketoconazole for Cancer-related Rash

Recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Must be taking: EGFR inhibitors

Disqualifiers: Allergy to ketoconazole, sulfites

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

58 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must continue using an EGFR inhibitor for at least 28 days during the trial.

What data supports the effectiveness of the drug Ketoconazole for treating cancer-related rash?

The research indicates that ketoconazole has been associated with drug-induced skin reactions in patients with acute non-lymphocytic leukemia, with an incidence rate of 18%. This suggests that ketoconazole can affect the skin, although this information is more about its potential to cause rashes rather than treat them. ^{1 2 3 4 5}

Is ketoconazole generally safe for human use?

Ketoconazole is generally considered safe for human use, but it can cause side effects like stomach issues, fatigue, and liver problems. Rarely, it can lead to serious liver damage and affect hormone levels, so monitoring is important. ^{6 7 8 9 10}

How does the drug ketoconazole differ from other treatments for cancer-related rash?

Ketoconazole is unique because it is an oral antifungal drug that also has antiandrogen effects, which means it can block male hormones like testosterone. This dual action is different from typical treatments for cancer-related rash, which may not address hormonal pathways. ^{7 9 10 11 12}

What is the purpose of this trial?

This trial studies how well ketoconazole, a skin-applied medication, works in treating rashes caused by cancer treatments. It targets cancer patients who have rashes from specific cancer medications. Ketoconazole may help by blocking certain hormones that cause the rash. Erlotinib is a potent medication approved for treatment of lung and pancreatic cancer.

Research Team

Aminah Jatoi, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for people with a rash or skin burning from EGFR inhibitor cancer treatment, who will continue this treatment for at least 28 days. Participants must be willing to complete quality-of-life questionnaires and may need to provide a skin biopsy. It's not open to those allergic to ketoconazole or sulfites.

Inclusion Criteria

I have a rash or burning skin from EGFR inhibitor treatment.

Mayo only: Patient is willing to provide a skin biopsy for correlative research; Note: Can be waived with permission of study chair (documentation such as an email must be provided)

I will start or continue an EGFR inhibitor treatment for at least 28 days soon.

Exclusion Criteria

You have had a bad reaction to ketoconazole before.

You are allergic or have a bad reaction to sulfites.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants apply ketoconazole or placebo topically twice daily for 28 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Ketoconazole

Trial Overview The study tests if ketoconazole can ease rashes caused by EGFR inhibitors in cancer patients. It involves comparing the effects of ketoconazole against a placebo while monitoring participants' quality of life through questionnaires and lab biomarker analysis.

Participant Groups

Group I: Arm I (ketoconazole) Experimental Treatment 4 Interventions

Participants apply ketoconazole topically BID on days 1-28.

Group II: Arm II (placebo) Placebo Group 4 Interventions

Participants apply placebo topically BID on days 1-28.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Ketoconazole demonstrated significant cytotoxic effects against various cancer cell lines, with the ability to inhibit 90% of colony growth at specific concentrations, indicating its potential as a treatment option.

The effective concentration of 10 micrograms/ml achievable in humans suggests that ketoconazole warrants further clinical evaluation for its use in treating human malignancies, particularly in breast and pancreatic cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytotoxicity of ketoconazole in malignant cell lines. Rochlitz, CF., Damon, LE., Russi, MB., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Side effects of targeted therapies: rash. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Drug-induced skin reactions in patients with acute non-lymphocytic leukaemia. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Predictability of antitumor efficacy of cetuximab plus irinotecan based on skin rash severity according to observation period in patients with metastatic colorectal cancer following failure of fluorouracil, irinotecan and oxaliplatin. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Management of epidermal growth factor receptor inhibitor-associated rash: a systematic review. [2016]

5. France pubmed.ncbi.nlm.nih.gov

The predictive role of skin rash with cetuximab and panitumumab in colorectal cancer patients: a systematic review and meta-analysis of published trials. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Cytotoxicity of ketoconazole in malignant cell lines. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Multicenter clinical evaluation of ketoconazole in the treatment of cutaneous fungal infections. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Ketoconazole: an orally effective antifungal agent. Mechanism of action, pharmacology, clinical efficacy and adverse effects. [2019]

9. New Zealand pubmed.ncbi.nlm.nih.gov

The treatment of advanced prostate cancer with ketoconazole: safety issues. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Ketoconazole. Mechanism of action, spectrum of activity, pharmacokinetics, drug interactions, adverse reactions and therapeutic use. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

A phase I clinical study of high dose ketoconazole plus weekly docetaxel for metastatic castration resistant prostate cancer. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Treatment of mycoses in cancer patients. [2019]