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Tetracycline in Preventing Sk...

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

Last Updated: 2017-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

tetracycline hydrochloride

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Interventions

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tetracycline hydrochloride

Intervention Type DRUG

placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aminah Jatoi, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

Site Status

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Site Status

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States

Site Status

St. Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Southwest Medical Center

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status