A Randomized, Open-label Phase III Trial of Mapisal® Versus an Urea Hand-foot Cream as Prophylaxis for Capecitabine-induced Hand-foot Syndrome in Patients With Gastrointestinal Tumors or Breast Cancer
18 Years
N/A
Both
the Treatment Hand-foot Syndrom Patients With Gastrointestinal Tumors or Breast Cancer, Who Are Treated With Capecitabine
Trial Information
A Randomized, Open-label Phase III Trial of Mapisal® Versus an Urea Hand-foot Cream as Prophylaxis for Capecitabine-induced Hand-foot Syndrome in Patients With Gastrointestinal Tumors or Breast Cancer
Hand-foot syndrome (HFS) is a frequently occurring, often dose limiting, dermatologic
reaction associated with cytotoxic agents, such as capecitabine, liposomal doxorubicin, and
doxetacel.
Adverse events affecting the integument have posed significant challenges to oncologists in
recent years in terms of selecting appropriate supportive therapies. Not only medications
that inhibit EGFR receptors such as erlotinib, gefitinib, panitumumab or cetuximab, but also
multiple-receptor tyrosine kinase inhibitors such as sunitinib and sorafenib and other
"older" medications such as capecitabine can often lead to skin-related adverse events that
can be difficult to manage.
These adverse events compromise skin-related quality of life and can lead to dose
compromises or even the termination of treatment.
To date, there are no side effects reported for the use of either Mapisal® or urea hand-foot
cream, making both treatments safe. Given the potential benefits of the treatments in
preventing HFS by reducing discomfort and impairment of quality of life, the conduct of the
trial is regarded as justifiable and there is no indication that patients are exposed to an
increased risk associated with study participation.
Inclusion Criteria:
1. Signed written informed consent
2. Male or female ≥18 years of age
3. Patients with gastrointestinal tumors or breast cancer who will be treated with
capecitabine according to label
4. Palliative or adjuvant chemotherapy with capecitabine (combination- or mono-therapy,
minimal dose of capecitabine 2000 mg/m2)
5. Life expectancy of least 12 weeks
6. WHO performance status 0-2
7. Adequate contraception
8. Willingness to fill in QoL forms
9. Laboratory requirements
- Platelet count ≥100 × 109/L
- Leukocyte count > 3.0 × 109/L
- Hemoglobin ≥ 10.0 g/dL
10. Resolution of all chemotherapy- or radiotherapy-related toxicities to grade 1 or
lower except for stable sensory neuropathy < grade 2. Any dermatological toxicities
other than alopecia resulting from previous chemotherapy or radiotherapy must be
completely resolved.
Exclusion Criteria:
1. Previous chemotherapy with capecitabine or liposomal doxorubicine, or any other
substance, i.e. tyrosine kinase inhibitors (such as sorafenib and sunitinib) that
may induce HFS
2. Radiotherapy or surgery within 4 weeks before start of treatment.
3. Dermatologic diseases that could interfere with the result of the clinical trial
4. Known drug/ alcohol abuse
5. Pregnant or breast feeding patients
6. Participation in another clinical trial and patient received investigational drug
within the last 30 days prior to treatment start (i.e. follow-up within a preceding
trial is not exclusionary)
7. Known allergic reactions to any of the ingredients of the ointments or capecitabine
Type of Study:
Expanded Access
Study Design:
N/A
Principal Investigator
Deniz Gencer, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Universitätsmedizin Mannheim
Authority:
Germany: German Institute of Medical Documentation and Information
Study ID:
AIO-LQ-0111
NCT ID:
NCT01626781
Start Date:
Completion Date:
Related Keywords:
- the Treatment Hand-foot Syndrom Patients With Gastrointestinal Tumors or Breast Cancer, Who Are Treated With Capecitabine
- Breast Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Neoplasms
Name | Location |
|---|
