SKIP - A Double-blind Placebo-controlled Randomized Multicenter Trial of Skin Toxicity Treatment

NCT ID: NCT01418742

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-05-31

Brief Summary

Skin toxicity treatment in patients with advanced or metastatic colorectal cancer (mCRC) and non-mutated (wild-type) KRAS treated with panitumumab monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Detailed Description

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.

Conditions

Colorectal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Doxycycline 100 mg BID oral use

Group Type: ACTIVE_COMPARATOR

Panitumumab, Doxycycline/Placebo

Intervention Type: DRUG

comparison of Doxycyline/Placebo and Panitumumab regarding efficacy of the therapy of panitumumab induced skin toxicity

Placebo 100 mg BID oral use

Group Type: PLACEBO_COMPARATOR

Panitumumab

Intervention Type: DRUG

mCRC patients receiving panitumumab as EGFR inhibitor.

Interventions

Panitumumab, Doxycycline/Placebo

comparison of Doxycyline/Placebo and Panitumumab regarding efficacy of the therapy of panitumumab induced skin toxicity

Intervention Type: DRUG

Panitumumab

mCRC patients receiving panitumumab as EGFR inhibitor.

Intervention Type: DRUG

Eligibility Criteria

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.

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 randomization

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ClinAssess GmbH

INDUSTRY

Sponsor Role: collaborator

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanno Riess, Prof.

Role: STUDY_CHAIR

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

Locations

DRK Kliniken Berlin / Köpenick, Klinik für Chirurgie

Berlin, , Germany

Onkologische Schwerpunktpraxis

Berlin, , Germany

Medizinisches Versorgungszentrum Ärzteforum Seestraße

Berlin, , Germany

Charité Campus Virchow Klinikum (CVK), Centrum für Tumormedizin, Medizinische Klinik mit Schwerpunkt Hämatologie u. Onkologie

Berlin, , Germany

Ärzteforum Bernau

Bernau, , Germany

Onkologische Schwerpunktpraxis

Brandenburg, , Germany

Städtisches Klinikum Dessau, Hömatologie und Internistische Onkologie

Dessau, , Germany

St. Georg Klinikum Eisenach gGmbH, Klinik für Innere Medizin 2

Eisenach, , Germany

Krankenhaus St. Elisabeth u. St. Barbara, Klinik für Allgemein- u. Visceralchirurgie

Halle, , Germany

Ärzteforum Hennigsdorf

Hennigsdorf, , Germany

eps-early phase GmbH

Jena, , Germany

Klinikum Dorothea Christiane Erxleben Quedlinburg gGmbH, Klinik f. Allgemein, Vizeral- und Gefäßchirurgie

Quedlinburg, , Germany

Countries

Germany

Other Identifiers

GMIHO-010/2009

Identifier Type: -

Identifier Source: org_study_id