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SKIP - A Double-blind Placebo-controlled Randomized Multicenter Phase II Trial of Skin Toxicity Treatment in Subjects With Advanced or Metastatic Colorectal Carcinoma Receiving Panitumumab

Phase 2
18 Years
Not Enrolling
Colorectal Carcinoma

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Trial Information

SKIP - A Double-blind Placebo-controlled Randomized Multicenter Phase II Trial of Skin Toxicity Treatment in Subjects With Advanced or Metastatic Colorectal Carcinoma Receiving Panitumumab

Because of their frequency and severity panitumumab associated skin toxicities affect
patients' quality of life and thus threaten patients' compliance to therapy. There is an
urgent need for evidence-based treatment recommendations for the prevention and management
of panitumumab -associated skin toxicities.

The study aims to compare the efficacy and safety of a manageable preemptive treatment with
oral doxycycline in combination with a supportive topical regimen containing erythromycin
cream (2 %) over duration of 12 weeks on the occurrence and grade of panitumumab induced
skin toxicities in a double-blind, controlled randomized setting. Basic skin treatment with
or without doxycycline will be discontinued at the end of study treatment after 12 weeks or
until a value of 6-10 is observed on the visual analogue scale (VAS), whichever is sooner.

Inclusion Criteria:

1. Patients with advanced or metastatic colorectal cancer (mCRC) and non-mutated
(wild-type) KRAS who are planned to receive treatment with panitumumab monotherapy
after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing
chemotherapy regimens and without prior treatment with epidermal growth factor
receptor (EGFR) antibody

2. Man or woman 18 years of age or older

3. Signed and dated informed consent before the start of specific protocol procedures

4. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2

5. Bilirubin ≤ 1.5 x ULN, SGOT/SGPT ≤ 2.5 x ULN, AP ≤ 3 x ULN if no evidence of liver
metastases or Bilirubin ≤ 3 x ULN, SGOT/SGPT ≤ 5 x ULN, AP ≤ 5 x ULN if evidence of
liver metastases

6. Women of child-bearing potential have to use adequate highly effective methods of
contraception . Since doxycyline may reduce efficacy of hormonal contraceptives,
women of child-bearing potential have to use double-barrier methods within 4 weeks
before first intake of study medication, during study participation and at least 6
weeks after last intake of study medication even if using hormonal contraceptives
Women are considered to be of child-bearing potential unless they are ≥ 50 years old
and for more than 2 years amenorrheic or unless they are surgically sterile.

Exclusion Criteria:

1. Absence of any of the above-listed inclusion criteria

2. Any serious medical condition or psychiatric illness that would interfere with the
patient's ability to sign the informed consent form.

3. Allergic reaction to one of the medications to be used

4. Subject allergic to panitumumab or any components of the panitumumab formulation or
treatment regimen

5. Prior treatment with EGFR antibody

6. CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital,
carbamazepine, ketoconazole, rifampicin, rifabutin, and St. John's Wort) ≤ 2 weeks
before randomization (itraconazole should be used with caution)

7. Subjects with hypersensitivity to doxycycline, other tetracyclines, or ingredients of
doxycycline capsules

8. Systemic treatment with antibiotics which was completed less than 7 days prior to

9. Pregnant and/or breast-feeding women

10. Active participation in other clinical studies in the previous 4 weeks

11. Serious liver function disorders

12. History of, or evidence of, interstitial pneumonitis or pulmonary fibrosis

13. Person who has been committed to an institution by virtue of an order issued either
by the judicial or the administrative authorities.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time until unblinding of skin therapy allocation (basic skin treatment with or without doxycycline) due to insufficient efficacy (i.e. unbearable skin toxicity, measured by patient's allocating point 6 through 10 on a visual analogue scale)

Outcome Time Frame:

30 month

Safety Issue:


Principal Investigator

Hanno Riess, Prof.

Investigator Role:

Study Chair

Investigator Affiliation:

Charité Campus Virchow Klinikum, Klinik für Innere Medizin mit Schwerpunkt Hämatologie u. Onkologie


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

August 2011

Completion Date:

November 2014

Related Keywords:

  • Colorectal Carcinoma
  • skin toxicity
  • Carcinoma
  • Colorectal Neoplasms