Phase II Trial Of ZK-EPO (ZK 219477) (Sagopilone) In Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: ZK-EPO
Intervention description: Participants were treated with 16 mg/m^2 of ZK-EPO (EpothiloneZK) (Sagopilone) administered as a single 3 hour intravenous infusion every 21 days. Prior to each treatment, participants were premedicated with either granisetron or ondansetron and additional anti-emetics if needed. Chemotherapy was continued until disease progression, withdrawal of consent, or for unacceptable treatment-associated toxicity.
Intervention MeSH terms: Sagopilone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ZK-EPO; ZK219477; EpothiloneZK

Summary:

      The purpose of this study is to find out how effective an investigational drug named ZK-Epo
      is against melanoma. Although ZK-Epo has been studied in the treatment of cancer, it is not
      approved for use in treating melanoma. This research is being done because currently there
      are only a limited number of treatment options for patients who have melanoma that has spread
      to distant organs.

      We expect each patient to be in this study for at least 2 cycles. One cycle lasts for 21
      days. If their tumor does not grow after 2 cycles and they do not have any major
      side-effects, they may receive up to 6 cycles of ZK-Epo.

      If after they have received 6 cycles of ZK-Epo and their doctor determines that the tumor is
      continuing to shrink, they will continue treatment with ZK-Epo. The number of treatments the
      patient receives after 6 cycles will depend upon when their doctor feels there has been
      maximum tumor response (tumor shrinkage). Two treatments will be given beyond what their
      doctor considers the point of maximum shrinkage. We estimate that they will spend anywhere
      from 1 1/2 months to 5 months taking part in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed Malignant Melanoma.

          -  Unresectable Stage III or Stage IV disease.

          -  At least 1 measurable lesion.

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

          -  Adequate function of major organs and systems as measured by the following criteria:

        Bone Marrow:

          -  Hemoglobin ≥ 10 g/dL

          -  White blood count (WBC) ≥ 3,000/mm^3

          -  Absolute neutrophil count (ANC) ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic:

          -  Bilirubin within 1.5 times normal limit

          -  aspartate transaminase (AST)/Alanine aminotransferase (ALT) ≤ 5 times the upper limit
             of normal (ULN)

        Renal:

          -  Creatinine ≤ 2 mg/dL

        Cardiovascular:

          -  No New York Heart Association (NYHA) class III or IV Congestive heart failure

          -  No unstable angina pectoris

          -  No arrhythmia needing continuous treatment

        Nervous system:

          -  No Grade ≥ 2 peripheral neuropathy

        Exclusion Criteria:

          -  More than 2 previous chemotherapy regimens.

          -  Any prior treatment with Epothilones, Epothilone analogues, taxanes, or vinca
             alkaloids.

          -  Any progressive central nervous system (CNS) metastatic disease. Patients with CNS
             metastases may be allowed if stable for 8 weeks or more and patient is neurologically
             intact and off of steroids. The stability must be documented by MRI/CT over a period
             of 8 weeks or greater.

          -  Any radiotherapy, chemotherapy, or immunotherapy within 3 weeks prior to first dose of
             ZK-Epo. If patients were previously on temozolomide with extended dose schedule, they
             must be off 1 week prior to the first dose of ZK-Epo.