Clinical trial · Interventional
Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer
An Exploratory, Placebo-Controlled Trial of Prophylactic Tetracycline for Gefitinib-or Cetuximab-Induced Skin Rash (or Other Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Skin Rash)
NCT00091247CI-TRIAL-00026488completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Tetracycline may be effective in preventing skin rash that is caused by treatment with drugs such as gefitinib or cetuximab. PURPOSE: This randomized clinical trial is studying tetracycline to see how well it works compared to placebo in preventing skin rash in patients who are receiving drugs such as gefitinib or cetuximab for cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| tetracycline hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- tetracycline
- description
- Patients receive oral tetracycline twice daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity. Quality of life is assessed at baseline and then weekly for 8 weeks. Patients are followed at weeks 4 and 8.
- interventionNames
- Drug: tetracycline hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- Patients receive oral placebo twice daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity. Quality of life is assessed at baseline and then weekly for 8 weeks. Patients are followed at weeks 4 and 8.
- interventionNames
- Other: placebo
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of cancer * Began therapy within the past 7 days or plans to begin therapy within 7 days after study entry with one of the following epidermal growth factor receptor inhibitors: * Gefitinib * Cetuximab * Erlotinib * Monoclonal antibody ABX-EGF * ICR-62 * CI-1033 * EMD-72000 * No rash at study entry PATIENT CHARACTERISTICS: Age * 18 and over Hepatic * Bilirubin ≤ 2 mg/dL Renal * Creatinine ≤ 2 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective non-hormonal contraception * Able to take oral medication * No history of skin condition that may flare during study treatment * No prior allergic reaction or severe intolerance to tetracycline or one of its derivatives * No severe nausea or vomiting that would preclude retaining study drug PRIOR CONCURRENT THERAPY: Other * More than 1 week since prior tetracycline * No milk products, antacids, or calcium supplements for 2 hours before until 2 hours after drug administration * No other concurrent tetracycline
References
Publications (4)
- BACKGROUNDAtherton PJ, Burger KN, Loprinzi CL, Neben Wittich MA, Miller RC, Jatoi A, Sloan JA. Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993). Support Care Cancer. 2012 Aug;20(8):1729-35. doi: 10.1007/s00520-011-1266-x. Epub 2011 Sep 16. PMID 21922203
- RESULTJatoi A, Dakhil SR, Sloan JA, Kugler JW, Rowland KM Jr, Schaefer PL, Novotny PJ, Wender DB, Gross HM, Loprinzi CL; North Central Cancer Treatment Group. Prophylactic tetracycline does not diminish the severity of epidermal growth factor receptor (EGFR) inhibitor-induced rash: results from the North Central Cancer Treatment Group (Supplementary N03CB). Support Care Cancer. 2011 Oct;19(10):1601-7. doi: 10.1007/s00520-010-0988-5. Epub 2010 Sep 6. PMID 20820817
- RESULTJatoi A, Rowland K, Sloan JA, Gross HM, Fishkin PA, Kahanic SP, Novotny PJ, Schaefer PL, Johnson DB, Tschetter LK, Loprinzi CL. Tetracycline to prevent epidermal growth factor receptor inhibitor-induced skin rashes: results of a placebo-controlled trial from the North Central Cancer Treatment Group (N03CB). Cancer. 2008 Aug 15;113(4):847-53. doi: 10.1002/cncr.23621. PMID 18543329
- RESULTJatoi A, Rowland K, Sloan JA, et al.: Does tetracycline prevent/palliate epidermal growth factor receptor (EGFR) inhibitor-induced rash? A phase III trial from the North Central Cancer Treatment Group (N03CB). [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA9006, 494s, 2007.