Phase II Trial Of ZK-EPO (ZK 219477) (Sagopilone) In Metastatic Melanoma

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: Bayer
• Treatments: Epothilones; Sagopilone

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.