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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Other: placebo; Drug: tetracycline hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00091247

NCI-2011-01620 (Registry Identifier)

CDR0000385682 (Registry Identifier)

NCCTG-N03CB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups, including a placebo group

tetracycline

Experimental group

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.

Treatment:

Drug: tetracycline hydrochloride

placebo

Placebo Comparator group

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.

Treatment:

Other: placebo