Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

September 7, 2004

Last Updated Date

July 9, 2009

Start Date ^ICMJE

December 2004

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Rash severity

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00091247 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer

Official Title ^ICMJE

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)

Brief Summary

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.

Detailed Description

OBJECTIVES:

Compare the 1-month incidence and severity of gefitinib-, cetuximab-, or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with tetracycline vs placebo.
Compare the toxicity of these drugs in these patients.
Compare the quality of life of patients treated with these drugs who develop vs those who do not develop a rash.
Determine whether patients who discontinue tetracycline at 1 month develop a rash.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior chemotherapy regimen (first-line therapy vs other), concurrent epidermal growth factor receptor inhibitor therapy (gefitinib vs cetuximab vs other), and concurrent corticosteroid therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral tetracycline twice daily.
Arm II: Patients receive oral placebo twice daily. In both arms, 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.

PROJECTED ACCRUAL: A total of 126 patients will be accrued for this study.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Double-Blind, Placebo Control

Condition ^ICMJE

Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^ICMJE

Drug: tetracycline hydrochloride

Study Arms / Comparison Groups

Publications *

Jatoi 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 Jun 9; [Epub ahead of print]

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

126

Completion Date

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

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:

Biologic therapy

See Disease Characteristics

Chemotherapy

Not specified

Endocrine therapy

No concurrent oral contraceptives

Radiotherapy

Not specified

Surgery

Not specified

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00091247

Responsible Party

Study ID Numbers ^ICMJE

CDR0000385682, NCCTG-N03CB

Study Sponsor ^ICMJE

North Central Cancer Treatment Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:	Aminah Jatoi, MD	Mayo Clinic
Investigator:	Charles L. Loprinzi, MD	Mayo Clinic

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP