Status:
TERMINATED
Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Renal Cell Carcinoma
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Brief 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, l...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion Criteria
- 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
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01466504
Start Date
May 1 2011
End Date
April 1 2013
Last Update
April 15 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
2
White River Junction VA Medical Center
White River Junction, Vermont, United States, 05009