Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma

Phase III Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma

The primary objective of this trial is to compare the survival of patients with metastatic malignant melanoma treated with Taxoprexin Injection to those treated with Dacarbazine. In addition, the response rate to each drug, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.

This was a randomized, multi-center, open-label Phase III study in patients with histologically confirmed metastatic malignant melanoma. Patients received either Taxoprexin® at a starting dose of 900 mg/m2 intravenously by 2-hour infusion on Day 1 every 3 weeks or dacarbazine at a starting dose of 1000 mg/m2 intravenously over at least 30 minutes once every 3 weeks. Treatment continued until progression of disease, intolerable toxicity, refusal of continued treatment by the patient, or, in the investigator's opinion, treatment discontinued. Disease status was assessed every 6 to 8 weeks using standard imaging techniques. All images were forwarded to the sponsor and archived. Following the end of protocol treatment, further treatment was at the investigator's discretion but no cross-over was planned. All patients were followed until death

Inclusion Criteria:

• Patients must have malignant melanoma, and documented metastatic disease.
• Patients must have at least one unidimensionally measurable lesion.
• Patients must not have received prior systemic chemotherapy for metastatic disease. Prior treatment with immunotherapy or vaccine therapy is allowed provided there is documentation of disease progression.
• At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during immunotherapy.
• At least 4 weeks (28 days) since any prior radiotherapy.
• Lesions being used to assess disease status may not have been radiated.
• Patients must have Eastern Cooperative Oncology Group performance status of 0 - 2.
• Patients must be >= 18 years of age.
• Patients must have adequate renal and liver function
• Patients must have adequate bone marrow function.
• Life expectancy of at least 3 months.
• Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.

Exclusion Criteria:

• Patients who have received prior therapy with any taxane or dacarbazine.
• Patients whose primary site is the eye.
• Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers cured by surgery alone with a disease-free survival longer than 5 years.
• Patients with uncontrolled brain metastasis.
• Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
• Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
• Patients with current peripheral neuropathy of any etiology that is greater than grade 1.
• Patients with unstable or serious concurrent medical conditions are excluded.
• Patients with a known hypersensitivity to Cremophor.
• Patients must not have had recent major surgery within the past 14 days or large field radiation therapy, chemotherapy, endocrine therapy in the last 28 days, or biologic therapy in the last 42 days.