Mouth DiseasesPhase 2NCT00230191
Safety and Efficacy of RK0202 in Oral Mucositis
A Phase 2 study testing RK-0202 in people with Mouth Diseases and Mouth Ulcers, run by RxKinetix at 9 sites in 2 countries.
Trial summary
The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis in subjects receiving radiation therapy for head and neck cancer. Concurrent chemotherapy is not allowed in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mouth Diseases, Mouth Ulcers, Oral Mucositis
- What is being tested?
- RK-0202
- How many people
- 110 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jan 2003to Dec 2005
- Phase
- Phase 2
- 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
Who may be able to join
- Males or females 18 years and older with confirmed tumors of the oral cavity, oropharynx, nasopharynx, salivary glands, or supraglottic region who are intended for treatment with RT alone (no concomitant chemotherapy).
- In post-operative patients, RT must begin no later than 9 weeks following surgery.
- Intended for treatment with an RT regimen that will deliver a minimum of 60 Gy over 5-8 weeks to at least 2cm2 of three or more of seventeen protocol-specific oral cavity anatomical sites. Each qualifying site must receive a minimum of 60 Gy and there must be at least three such sites. (See section 5.3.1). Regimens may consist of:
- single dose daily fractionated (daily max 2.2 Gy)
- hyperfractionated (daily max 2.4 Gy)
- concurrent boost (daily max during boost 3.3 Gy)
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- The minimum planned duration of treatment must be 5 weeks and the maximum 8 weeks.
- Ability to undergo oral assessments.
- Ability to begin dosing with study drug on day 1 of RT.
- Karnofsky Performance Score > 60.
- Ability to understand the protocol and provide informed consent.
- If female, have negative serum pregnancy test.
Who cannot join
- Planned use of concomitant chemotherapy.
- Planned use of amifostine.
- Presence of oral mucositis.
- Prior radiotherapy to the head and neck.
- T1 or T2 glottic tumors.
- Other investigational drugs in the 14 days preceding initiation of study medication or during administration of study medication.
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- Other investigational or mucoprotective therapy for the prevention of oral mucositis, including, but not limited to, -carotene, tocopherol, laser irradiation, brushing the oral mucosa with silver-nitrate prophylactically, systemic TGF-β (transforming growth factor beta), misoprostol, pentoxifylline, leucovorin, allopurinol mouthwashes, systemic KGF (keratinocyte growth factor) or pilocarpine. Oral rinses with hydrogen peroxide, sucralfate, or chlorhexidine gluconate are also not permitted during the study.
- Serious recent non-malignant medical condition which, in the opinion of the investigator, makes the patient unsuitable for study participation.
- Medical, sociological, or psychological impediment to probable compliance with protocol.
- Inability to undergo repeat treatments, clinical evaluations and other diagnostic procedures required by the protocol.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
University of Connecticutt
Farmington, Massachusetts, 06030
MD Anderson Cancer Center
Houston, Texas, 77030
UCLA Medical Center
Los Angeles, California, 90095
Commonwealth ENT
Louisville, Kentucky, 40207
H Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Medical University of Ohio, Cancer Institute Ruppert Cancer Center
Toledo, Ohio, 43614
Canada3 sites
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2
Juravinski Cancer Center
Hamilton, Ontario, L8V5C2
University of Ottawa
Ottawa, Ontario, K1H1C4
About this study
Official title: Phase II, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of the Effects of RK-0202 on Oral Mucositis in Patients Receiving Radiation Therapy for Tumors of the Oral Cavity, Oropharynx, Nasopharynx, Salivary Glands or Supraglottic Region
The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis in subjects receiving radiation therapy for head and neck cancer. Concurrent chemotherapy is not allowed in the study.
Read the detailed description
Approximately 42,000 new cases of head and neck squamous cell carcinoma occur annually in the United States. Radiotherapy ("RT") plays a significant role in the management of head and neck cancer. The most common and clinically significant toxicities arising from head and neck radiation therapy are acute mucositis and acute and chronic xerostomia (dry mouth or salivary gland changes). In subjects receiving RT for cancers of the oral cavity or oropharynx the incidence of acute mucositis can exceed 90%. The painful ulceration of the oral mucosa produced by the radiation often leads to the requirement for narcotics to control pain, inability to eat, dehydration, the need for parenteral nutrition and, sometimes, breaks in RT. In addition to its symptomatic cost, the presence of mucositis has been associated with a number of other adverse outcomes including higher costs and more frequent hospitalizations.
- Conditions
- Mouth Diseases, Mouth Ulcers, Oral Mucositis, Head and Neck Cancer
- Being tested
- RK-0202
- Keywords
- Oral, Mucositis, Stomatitis, Head and Neck Cancer
- Medical subject headings
- Mouth Diseases, Oral Ulcer, Stomatitis, Head and Neck Neoplasms, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RK-0202Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis.
Secondary outcomes (1)
The secondary objectives of the study are to assess the safety and tolerability of RK-0202 in these subjects and to explore whether the ProGelz™ vehicle alone is active in these subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startJan 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth DiseasesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 110 participants
Sponsor and investigators
- Lead sponsor
- RxKinetix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steve Sonis, DMD DMSc, Study director, Harvard, Oral Medicine, Infection & ImmunologyDoug Peterson, DMD, Principal investigator, University of Connecticutt Health CenterGuy Juillard, MD, Principal investigator, University of California, Los AngelesMark Chambers, DMD MS, Principal investigator, MD AndersonAndy Trotti, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research InstituteJohn Feldmeier, DO, Principal investigator, Medical University of OhioSamy El Sayed, MD, Principal investigator, Ottawa Regional Cancer CentreRufus Scrimger, MD, Principal investigator, Cross Cancer Institute, Edmonton, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230191
- Sponsor's protocol ID
- RK:0202-02
- Status last verified
- Oct 2005
- First submitted
- 28 Sep 2005
- Last updated
- 15 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of the Effects of RK-0202 on Oral Mucositis in Patients Receiving Radiation Therapy for Tumors of the Oral Cavity, Oropharynx, Nasopharynx, Salivary Glands or Supraglottic Region
- ClinicalTrials.gov ID
- NCT00230191
- Acronym / sponsor ID
- RK:0202-02
- Conditions
- Mouth Diseases, Mouth Ulcers, Oral Mucositis, Head and Neck Cancer
- Keywords
- Oral, Mucositis, Stomatitis, Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants
- Lead sponsor
- RxKinetixIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Dec 2005
- First posted
- 30 Sep 2005 (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.
The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis in subjects receiving radiation therapy for head and neck cancer. Concurrent chemotherapy is not allowed in the study.
Detailed description
Approximately 42,000 new cases of head and neck squamous cell carcinoma occur annually in the United States. Radiotherapy ("RT") plays a significant role in the management of head and neck cancer. The most common and clinically significant toxicities arising from head and neck radiation therapy are acute mucositis and acute and chronic xerostomia (dry mouth or salivary gland changes). In subjects receiving RT for cancers of the oral cavity or oropharynx the incidence of acute mucositis can exceed 90%. The painful ulceration of the oral mucosa produced by the radiation often leads to the requirement for narcotics to control pain, inability to eat, dehydration, the need for parenteral nutrition and, sometimes, breaks in RT. In addition to its symptomatic cost, the presence of mucositis has been associated with a number of other adverse outcomes including higher costs and more frequent hospitalizations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males or females 18 years and older with confirmed tumors of the oral cavity, oropharynx, nasopharynx, salivary glands, or supraglottic region who are intended for treatment with RT alone (no concomitant chemotherapy).
- In post-operative patients, RT must begin no later than 9 weeks following surgery.
- Intended for treatment with an RT regimen that will deliver a minimum of 60 Gy over 5-8 weeks to at least 2cm2 of three or more of seventeen protocol-specific oral cavity anatomical sites. Each qualifying site must receive a minimum of 60 Gy and there must be at least three such sites. (See section 5.3.1). Regimens may consist of:
- single dose daily fractionated (daily max 2.2 Gy)
- hyperfractionated (daily max 2.4 Gy)
Key exclusion criteria (10 listed)
- Planned use of concomitant chemotherapy.
- Planned use of amifostine.
- Presence of oral mucositis.
- Prior radiotherapy to the head and neck.
- T1 or T2 glottic tumors.
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 |
|---|---|---|
| RK-0202 | Drug | – |
Primary outcome
The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis.
1 secondary outcome
The secondary objectives of the study are to assess the safety and tolerability of RK-0202 in these subjects and to explore whether the ProGelz™ vehicle alone is active in these subjects.
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 15 Jan 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.
Steve Sonis, DMD DMSc study director
Harvard, Oral Medicine, Infection & Immunology
Doug Peterson, DMD principal investigator
University of Connecticutt Health Center
Guy Juillard, MD principal investigator
University of California, Los Angeles
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RK-0202 in people with Mouth Diseases and Mouth Ulcers, run by RxKinetix at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. 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 15 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2007.