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

NCT01418742 | Terminated Phase 2

• 1 other identifier: GMIHO-010/2009
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 12

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.

Conditions

Colorectal Carcinoma

Keywords

skin toxicity

Outcome Measures

Primary Outcomes (1)

• 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)

  30 month

Secondary Outcomes (13)

• Incidence of specific ≥ grade 2 skin toxicities over 12 weeks or until a value of 6-10 is observed on the VAS, whichever is sooner

  30 months

• Time to first occurrence of specific ≥ grade 2 skin toxicities

  30 months

• Most severe specific ≥ grade 3 skin toxicities of interest over 12 weeks or until a value of 6-10 is observed on the VAS, whichever is sooner

  30 months

• Time to the first most severe specific ≥ grade 3 skin toxicities

  30 month

• Incidence of panitumumab dose reduction due to the specific skin toxicities of interest over 12 weeks or until a value of 6-10 is observed on the VAS, whichever is sooner

  30 month

Study Arms (2)

Doxycycline 100 mg BID oral use

ACTIVE COMPARATOR

Drug: Panitumumab, Doxycycline/Placebo

Placebo 100 mg BID oral use

PLACEBO COMPARATOR

Drug: Panitumumab

Interventions

Panitumumab, Doxycycline/Placebo DRUG

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

Doxycycline 100 mg BID oral use

Panitumumab DRUG

mCRC patients receiving panitumumab as EGFR inhibitor.

Placebo 100 mg BID oral use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Man or woman 18 years of age or older
• Signed and dated informed consent before the start of specific protocol procedures
• ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2
• 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
• 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.

You may not qualify if:

• Any serious medical condition or psychiatric illness that would interfere with the patient's ability to sign the informed consent form.
• Allergic reaction to one of the medications to be used
• Subject allergic to panitumumab or any components of the panitumumab formulation or treatment regimen
• Prior treatment with EGFR antibody
• 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)
• Subjects with hypersensitivity to doxycycline, other tetracyclines, or ingredients of doxycycline capsules
• Systemic treatment with antibiotics which was completed less than 7 days prior to randomization
• Pregnant and/or breast-feeding women
• Active participation in other clinical studies in the previous 4 weeks
• Serious liver function disorders
• History of, or evidence of, interstitial pneumonitis or pulmonary fibrosis
• Person who has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

Sponsors & Collaborators

• Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH: lead
• ClinAssess GmbH: collaborator

Study Sites (12)

DRK Kliniken Berlin / Köpenick, Klinik für Chirurgie

Berlin, 12559, Germany

Location

Onkologische Schwerpunktpraxis

Berlin, 13055, Germany

Location

Medizinisches Versorgungszentrum Ärzteforum Seestraße

Berlin, 13347, Germany

Location

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

Berlin, 13355, Germany

Location

Ärzteforum Bernau

Bernau, 16321, Germany

Location

Onkologische Schwerpunktpraxis

Brandenburg, 14770, Germany

Location

Städtisches Klinikum Dessau, Hömatologie und Internistische Onkologie

Dessau, 06847, Germany

Location

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

Eisenach, 99817, Germany

Location

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

Halle, 06110, Germany

Location

Ärzteforum Hennigsdorf

Hennigsdorf, 16761, Germany

Location

eps-early phase GmbH

Jena, 07743, Germany

Location

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

Quedlinburg, 06484, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Panitumumab; Doxycycline

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Hanno Riess, Prof.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 17, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 14, 2014

Record last verified: 2013-03

Locations

DE (12)