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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00091247

Collaborator

National Cancer Institute (NCI) (NIH)

130

Enrollment

Locations

Arms

Duration (Months)

1.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: tetracycline hydrochloride Other: placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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)

Study Start Date :

Dec 1, 2004

Actual Primary Completion Date :

Aug 1, 2005

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.	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.	Other: placebo

Arm

Intervention/Treatment

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.

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.

Other: placebo

Outcome Measures

Primary Outcome Measures

Rash severity [Up to 8 weeks]
1-month incidence and severity [Up to 8 weeks]

Secondary Outcome Measures

quality of life [Up to 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60504
2	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
3	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
4	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
5	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
6	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa	United States	52403
7	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
8	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
9	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
10	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
11	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
12	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
13	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
14	Southwest Medical Center	Liberal	Kansas	United States	67901
15	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
16	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
17	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
18	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67042
19	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
20	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67208
21	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
22	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
23	CCOP - Wichita	Wichita	Kansas	United States	67214
24	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
25	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
26	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
27	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
28	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
29	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
30	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
31	Hurley Medical Center	Flint	Michigan	United States	48503
32	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
33	Foote Memorial Hospital	Jackson	Michigan	United States	49201
34	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan	United States	48144
35	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
36	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
37	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
38	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
39	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
40	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
41	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
42	St. John Macomb Hospital	Warren	Michigan	United States	48093
43	MeritCare Bemidji	Bemidji	Minnesota	United States	56601
44	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota	United States	55805-1983
45	CCOP - Duluth	Duluth	Minnesota	United States	55805
46	Miller - Dwan Medical Center	Duluth	Minnesota	United States	55805
47	Immanuel St. Joseph's	Mankato	Minnesota	United States	56002
48	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
49	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
50	MeritCare Broadway	Fargo	North Dakota	United States	58122
51	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
52	Hematology Oncology Center	Elyria	Ohio	United States	44035
53	Lima Memorial Hospital	Lima	Ohio	United States	45804
54	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537
55	St. Luke's Hospital	Maumee	Ohio	United States	43537
56	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
57	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
58	Firelands Regional Medical Center	Sandusky	Ohio	United States	44870
59	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
60	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
61	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
62	Toledo Hospital	Toledo	Ohio	United States	43606
63	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
64	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
65	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
66	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
67	Fulton County Health Center	Wauseon	Ohio	United States	43567
68	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia	United States	22401
69	Franciscan Skemp Healthcare - La Crosse Campus	La Crosse	Wisconsin	United States	54601

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Investigators

Study Chair: Aminah Jatoi, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Atherton 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.

Responsible Party:

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT00091247

Other Study ID Numbers:

NCCTG-N03CB
NCI-2011-01620
CDR0000385682

First Posted:

Sep 9, 2004

Last Update Posted:

Mar 16, 2017

Last Verified:

Mar 1, 2017

Keywords provided by Alliance for Clinical Trials in Oncology

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Exanthema

Tetracycline

Study Results

No Results Posted as of Mar 16, 2017