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 (PROCAPP)

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
AIO-Studien-gGmbH
ClinicalTrials.gov Identifier:
NCT01626781
First received: June 21, 2012
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

The purpose of this study is the examination of Mapisal® versus urea hand-foot cream as prophylaxis for capecitabine-induced hand-foot syndrome (HFS) in patients with gastrointestinal tumors or breast cancer, to assess the efficacy of Mapisal®.

Mapisal® is a medical device that is approved for the prophylaxis and treatment of HFS. Initial clinical data and case studies on the treatment and prophylaxis of Caelyx-induced HFS have been impressive. Because the pathomechanism of HFS caused by capecitabine is the same as for Caelyx-induced HFS, it is expected reason that administering Mapisal® should result in a significant reduction of HFS caused by capecitabine. The urea hand-foot cream was selected for the standard arm, because it is used commonly, is accepted by patients, and seems to have a positive influence on the severity of the HFS in the experience of many oncologists.


Condition Intervention
the Treatment Hand-foot Syndrome Patients With Gastrointestinal Tumors or Breast Cancer, Who Are Treated With Capecitabine
Device: Mapisal
Other: Urea hand-foot cream

Study Type: Expanded Access     What is Expanded Access?
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AIO-Studien-gGmbH:

Intervention Details:
    Device: Mapisal
    Mapisal® ointment will be applied to hand and feet three times daily, as well as after washing hands. Treatment should start 2 days prior to the first chemotherapy cycle with capecitabine and will continue daily for the first 6 weeks of chemotherapy.
    Other: Urea hand-foot cream
    Urea hand-foot cream will be applied to hand and feet three times daily, as well as after washing hands. Treatment should start 2 days prior to the first chemotherapy cycle with capecitabine and will continue daily for the first 6 weeks of chemotherapy.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626781

Locations
Germany
Universitätsmedizin Mannheim, III. Medizinische Klinik
Mannheim, Germany, 68167
Sponsors and Collaborators
AIO-Studien-gGmbH
Investigators
Principal Investigator: Deniz Gencer, Dr. Universitätsmedizin Mannheim
  More Information

Additional Information:
No publications provided

Responsible Party: AIO-Studien-gGmbH
ClinicalTrials.gov Identifier: NCT01626781     History of Changes
Other Study ID Numbers: AIO-LQ-0111
Study First Received: June 21, 2012
Last Updated: October 21, 2013
Health Authority: Germany: German Institute of Medical Documentation and Information
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hand-Foot Syndrome
Syndrome
Breast Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Disease
Pathologic Processes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Drug Eruptions
Dermatitis
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Digestive System Diseases
Gastrointestinal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014