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

• Conditions: Skin toxicity treatment in patients with wild-type KRAS metastatic colorectal cancer (mCRC) treated with panitumumab• In first-line in combination with FOLFOX• In second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan)• As monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens; MedDRA version: 16.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2010-019564-37-DE
• Lead Sponsor: GMIHO Gesellschaft für Medizinische Innovation – Hämatologie und Onkologie mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-26
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Patients with wild-type KRAS metastatic colorectal cancer (mCRC) who are planned to receive treatment with panitumumab
-> In first-line in combination with FOLFOX or
-> In second-line in combination with FOLFIRI if they have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) or
As monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens
and who did not receive any 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 adaequate 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 amenorrhoic or unless they are surgically sterile

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified