Clinical trial NCT01418742 (phase 2, status: terminated)
Conditions: colorectal carcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: panitumumab, doxycycline/placebo, panitumumab
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Reason stopped: 
    recruitement did not meet expectations. prev. differentiation of ras-wild-type and mutated ras
    are not in accordance with the scientific rank anymore.
  
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.

        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
             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.