Renal Cell CarcinomaNCT01466504
Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin
An observational study of Renal Cell Carcinoma and Hepatocellular Carcinoma, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
Skin toxicity is a frequently observed side effect in the era of "molecularly targeted therapies". Skin toxicity following administration of protein kinase inhibitors such as sorafenib, regorafenib, lapatinib, sunitinib, and others can be debilitating to the patient, resulting in dose reduction and discontinuation of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Hepatocellular Carcinoma, Colorectal Carcinoma
- What is being tested?
- skin punch biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to Apr 2013
- Phase
- Observational
- 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
Study population: Cancer diagnosis of Renal Cell Carcinoma (RCC) or Hepatocellular Carcinoma (HCC) or Colorectal Carcinoma
Who may be able to join
- Male or female, 18 years old or older.
- Histologically or cytologically confirmed diagnosis of a solid tumor (RCC, HCC, or colorectal cancer).
- Participants are planning to initiate treatment with either sorafenib or regorafenib as a single chemotherapeutic agent
- Able to swallow and retain oral medication and does not have any clinically relevant, active gastrointestinal disease or other condition that may significantly alter absorption, distribution, metabolism, or excretion of drugs.
- Be able to provide written informed consent.
Who cannot join
- Patients who are or will be receiving other chemotherapeutic or molecularly targeted agents in addition to sorafenib or regorafenib
- Concurrent moderate or severe chronic inflammatory skin condition (eczema, psoriasis)
- Concurrent blistering skin disorder of any severity (such as pemphigus, bullous pemphigoid)
- Connective tissue disorders with skin involvement (systemic lupus erythematosus, scleroderma, dermatomyositis, etc.)
- Patients manifesting an allergic skin reaction (such as urticaria) or skin reaction as a complication of prior chemotherapy
- Patients with skin lesions of infectious or non-infectious cause, precluding skin biopsy
Show all 10Show fewer
- Patients not willing to undergo skin biopsy
- Patients who are pregnant or planning to become pregnant during their participation in the study.
- Chemotherapy, targeted therapy, or biological therapy within two weeks of start of treatment.
- Ability to give informed consent is compromised by cognitive and/or decisional impairment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
White River Junction VA Medical Center
White River Junction, Vermont, 05009
About this study
Official title: A Study of the Effect of Sorafenib or Regorafenib on p63 Expression and Keratinocyte Differentiation in Human Skin
Skin toxicity is a frequently observed side effect in the era of "molecularly targeted therapies". Skin toxicity following administration of protein kinase inhibitors such as sorafenib, regorafenib, lapatinib, sunitinib, and others can be debilitating to the patient, resulting in dose reduction and discontinuation of treatment. The mechanisms of skin toxicity induced by targeted chemotherapy, such as sorafenib or regorafenib, are poorly understood. Further research is warranted to better understand the pathophysiology of drug-related skin toxicity in this setting and develop correction strategies. This study tests the hypothesis that sorafenib and regorafenib interfere with p63 expression and keratinocyte differentiation and skin remodeling.
Eligible study participants will be evaluated clinically for evidence of skin toxicity during their visits to the outpatient Oncology clinics. Study participants will undergo skin biopsies before sorafenib or regorafenib treatment is initiated and once rash develops or 12 weeks into treatment with sorafenib or regorafenib. Skin biopsies will be performed in Oncology clinics by the study investigators and clinic support staff.
Study participants will undergo both skin biopsies regardless of whether they develop a rash. In patients who develop a rash the most representative lesion will be biopsied. A normal appearing area of skin will be biopsied in participants who do not develop a rash.
- Being tested
- skin punch biopsy
- Keywords
- P63, Sorafenib, Regorafenib, rash, skin toxicity, RCC, HCC, colorectal carcinoma
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma, Hepatocellular, Colorectal Neoplasms, Ectrodactyly, Ectodermal Dysplasia, and Cleft Lip-Palate Syndrome 3, Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin punch biopsyProcedure or surgery
Skin biopsy prior to sorafenib or regorafenib treatment and when rash appears or 12 weeks into treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
p63 expression levels
Tissue collection is done within 7 days prior to treatment and when rash develops. If no rash develops, normal skin will be biopsied at week twelve of treatment.
Measured: Week 12
Secondary outcomes (1)
Tumor response
Sorafenib and regorafenib potentially interfere with p63 expression and keratinocyte differentiation and skin remodeling. The extent of interference may indicate extent of tumor response.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Accrual did not meet expectations. Over nearly 2 years just 4 subjects were treated on study. The goal of 30 subjects was not attainable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexey V Danilov, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466504
- Sponsor's protocol ID
- D11004
- Status last verified
- Mar 2013
- First submitted
- 31 Oct 2011
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Sorafenib or Regorafenib on p63 Expression and Keratinocyte Differentiation in Human Skin
- ClinicalTrials.gov ID
- NCT01466504
- Acronym / sponsor ID
- D11004
- Keywords
- P63, Sorafenib, Regorafenib, rash, skin toxicity, RCC, HCC, colorectal carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Accrual did not meet expectations. Over nearly 2 years just 4 subjects were treated on study. The goal of 30 subjects was not attainable.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 8 Nov 2011 (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.
Skin toxicity is a frequently observed side effect in the era of "molecularly targeted therapies". Skin toxicity following administration of protein kinase inhibitors such as sorafenib, regorafenib, lapatinib, sunitinib, and others can be debilitating to the patient, resulting in dose reduction and discontinuation of treatment. The mechanisms of skin toxicity induced by targeted chemotherapy, such as sorafenib or regorafenib, are poorly understood. Further research is warranted to better understand the pathophysiology of drug-related skin toxicity in this setting and develop correction strategies. This study tests the hypothesis that sorafenib and regorafenib interfere with p63 expression and keratinocyte differentiation and skin remodeling.
Eligible study participants will be evaluated clinically for evidence of skin toxicity during their visits to the outpatient Oncology clinics. Study participants will undergo skin biopsies before sorafenib or regorafenib treatment is initiated and once rash develops or 12 weeks into treatment with sorafenib or regorafenib. Skin biopsies will be performed in Oncology clinics by the study investigators and clinic support staff.
Study participants will undergo both skin biopsies regardless of whether they develop a rash. In patients who develop a rash the most representative lesion will be biopsied. A normal appearing area of skin will be biopsied in participants who do not develop a rash.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer diagnosis of Renal Cell Carcinoma (RCC) or Hepatocellular Carcinoma (HCC) or Colorectal Carcinoma
Key inclusion criteria (5 listed)
- Male or female, 18 years old or older.
- Histologically or cytologically confirmed diagnosis of a solid tumor (RCC, HCC, or colorectal cancer).
- Participants are planning to initiate treatment with either sorafenib or regorafenib as a single chemotherapeutic agent
- Able to swallow and retain oral medication and does not have any clinically relevant, active gastrointestinal disease or other condition that may significantly alter absorption, distribution, metabolism, or excretion of drugs.
- Be able to provide written informed consent.
Key exclusion criteria (10 listed)
- Patients who are or will be receiving other chemotherapeutic or molecularly targeted agents in addition to sorafenib or regorafenib
- Concurrent moderate or severe chronic inflammatory skin condition (eczema, psoriasis)
- Concurrent blistering skin disorder of any severity (such as pemphigus, bullous pemphigoid)
- Connective tissue disorders with skin involvement (systemic lupus erythematosus, scleroderma, dermatomyositis, etc.)
- Patients manifesting an allergic skin reaction (such as urticaria) or skin reaction as a complication of prior chemotherapy
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 |
|---|---|---|
| skin punch biopsySkin biopsy prior to sorafenib or regorafenib treatment and when rash appears or 12 weeks into treatment. | Procedure or surgery | – |
Primary outcome
p63 expression levels
Time frame: Week 12
Tissue collection is done within 7 days prior to treatment and when rash develops. If no rash develops, normal skin will be biopsied at week twelve of treatment.
1 secondary outcome
Tumor response
Time frame: Week 12
Results and safety
The study was stopped early (reason given: Accrual did not meet expectations. Over nearly 2 years just 4 subjects were treated on study. The goal of 30 subjects was not attainable.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
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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.
Alexey V Danilov, MD principal investigator
Dartmouth-Hitchcock Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma and Hepatocellular Carcinoma, run by Dartmouth-Hitchcock Medical Center at 2 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?
The sponsor lists 5 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: stopped early, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 was stopped early (reason given: Accrual did not meet expectations. Over nearly 2 years just 4 subjects were treated on study. The goal of 30 subjects was not attainable.). Results are not available in the source record.
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?
p63 expression levels (time frame: Week 12). 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 Apr 2013.