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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00091247
First received: September 7, 2004
Last updated: July 7, 2015
Last verified: July 2015

September 7, 2004
July 7, 2015
December 2004
July 2009   (final data collection date for primary outcome measure)
  • Rash severity [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
  • 1-month incidence and severity [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00091247 on ClinicalTrials.gov Archive Site
quality of life [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: tetracycline hydrochloride
  • Other: placebo
  • Experimental: tetracycline

    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.

    Intervention: Drug: tetracycline hydrochloride
  • Placebo Comparator: placebo

    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.

    Intervention: Other: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00091247
NCCTG-N03CB, NCI-2011-01620, CDR0000385682
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Aminah Jatoi, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2015

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