Unspecified Adult Solid Tumor, Protocol SpecificNCT00091247
Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer
A study testing tetracycline hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Alliance for Clinical Trials in Oncology at 69 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- tetracycline hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 69 sitesUnited States
- Study dates
- Dec 2004to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
69 sites in 1 country.
69 sites in 1 country
United States69 sites
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
Rush-Copley Cancer Care Center
Aurora, Illinois, 60504
MeritCare Bemidji
Bemidji, Minnesota, 56601
Wood County Oncology Center
Bowling Green, Ohio, 43402
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, 55805-1983
CCOP - Duluth
Duluth, Minnesota, 55805
Miller - Dwan Medical Center
Duluth, Minnesota, 55805
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042
Hematology Oncology Center
Elyria, Ohio, 44035
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122
MeritCare Broadway
Fargo, North Dakota, 58122
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Hurley Medical Center
Flint, Michigan, 48503
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236
Foote Memorial Hospital
Jackson, Michigan, 49201
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, 54601
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, 48144
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811
Southwest Medical Center
Liberal, Kansas, 67901
Lima Memorial Hospital
Lima, Ohio, 45804
St. Mary Mercy Hospital
Livonia, Michigan, 48154
Immanuel St. Joseph's
Mankato, Minnesota, 56002
Northwest Ohio Oncology Center
Maumee, Ohio, 43537
St. Luke's Hospital
Maumee, Ohio, 43537
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360
Community Cancer Center of Monroe
Monroe, Michigan, 48162
Mercy Memorial Hospital - Monroe
Monroe, Michigan, 48162
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114
St. Charles Mercy Hospital
Oregon, Ohio, 43616
Toledo Clinic - Oregon
Oregon, Ohio, 43616
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67042
Firelands Regional Medical Center
Sandusky, Ohio, 44870
North Coast Cancer Care, Incorporated
Sandusky, Ohio, 44870
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104
Flower Hospital Cancer Center
Sylvania, Ohio, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883
Toledo Hospital
Toledo, Ohio, 43606
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614
CCOP - Toledo Community Hospital
Toledo, Ohio, 43617
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, 43623
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
St. John Macomb Hospital
Warren, Michigan, 48093
Fulton County Health Center
Wauseon, Ohio, 43567
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214
CCOP - Wichita
Wichita, Kansas, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156
About this study
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)
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.
Read the 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.
- Being tested
- tetracycline hydrochloride, placebo
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tetracycline hydrochlorideDrug
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| tetracycline | Experimental | 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. Receives: Drug: tetracycline hydrochloride |
| placebo | Placebo comparator | 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rash severity
Measured: Up to 8 weeks
1-month incidence and severity
Measured: Up to 8 weeks
Secondary outcomes (1)
quality of life
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2004 (estimated)
- Study startDec 2004
- Primary completionAug 2005
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aminah Jatoi, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091247
- Sponsor's protocol ID
- NCCTG-N03CB
- Other IDs
- NCI-2011-01620, CDR0000385682
- Status last verified
- Mar 2017
- First submitted
- 7 Sep 2004
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21922203Jatoi A, Dakhil SR, Sloan JA, Kugler JW, Rowland KM Jr, Schaefer PL, Novotny PJ, Wender DB, Gross HM, Loprinzi CL; North Central Cancer Treatment Group. Prophylactic tetracycline does not diminish the severity of epidermal growth factor receptor (EGFR) inhibitor-induced rash: results from the North Central Cancer Treatment Group (Supplementary N03CB). Support Care Cancer. 2011 Oct;19(10):1601-7. doi: 10.1007/s00520-010-0988-5. Epub 2010 Sep 6.
PubMed 20820817Jatoi 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 Aug 15;113(4):847-53. doi: 10.1002/cncr.23621.
PubMed 18543329Jatoi A, Rowland K, Sloan JA, et al.: Does tetracycline prevent/palliate epidermal growth factor receptor (EGFR) inhibitor-induced rash? A phase III trial from the North Central Cancer Treatment Group (N03CB). [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA9006, 494s, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00091247
- Acronym / sponsor ID
- NCCTG-N03CB
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tetracycline | Experimental | Drug: tetracycline hydrochloridePatients 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. |
| placebo | Placebo comparator | Other: placeboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tetracycline hydrochloride | Drug | tetracycline |
| placebo | Other | placebo |
Primary outcome
Rash severity
Time frame: Up to 8 weeks
1-month incidence and severity
Time frame: Up to 8 weeks
1 secondary outcome
quality of life
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Background: PubMed 21922203Atherton 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.
- Results publication: PubMed 20820817Jatoi A, Dakhil SR, Sloan JA, Kugler JW, Rowland KM Jr, Schaefer PL, Novotny PJ, Wender DB, Gross HM, Loprinzi CL; North Central Cancer Treatment Group. Prophylactic tetracycline does not diminish the severity of epidermal growth factor receptor (EGFR) inhibitor-induced rash: results from the North Central Cancer Treatment Group (Supplementary N03CB). Support Care Cancer. 2011 Oct;19(10):1601-7. doi: 10.1007/s00520-010-0988-5. Epub 2010 Sep 6.
- Results publication: PubMed 18543329Jatoi 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 Aug 15;113(4):847-53. doi: 10.1002/cncr.23621.
- Results publicationJatoi A, Rowland K, Sloan JA, et al.: Does tetracycline prevent/palliate epidermal growth factor receptor (EGFR) inhibitor-induced rash? A phase III trial from the North Central Cancer Treatment Group (N03CB). [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA9006, 494s, 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aminah Jatoi, MD study chair
Mayo Clinic
69 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tetracycline hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Alliance for Clinical Trials in Oncology at 69 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rash severity (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00091247, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.