Phase II Open-Label Study of Weekly Taxoprexin (DHA-Paclitaxel) Injection as First Line Treatment of Patients With Metastatic Non-Choroidal Melanoma
1. Patients must have malignant skin/mucosal (non-choroidal) melanoma, and documented
2. Patients must have at least one measurable lesion.
3. Patients must not have received prior systemic chemotherapy for metastatic disease.
Prior treatment with immunotherapy or vaccine therapy is allowed.
4. At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine
or other therapy.
5. At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow and
prior adjuvant chemotherapy.
6. Patients must have ECOG performance status of 0 - 2.
7. Patients must be > 13 years of age. The safety of Taxoprexin has not been adequately
studied in younger patients.
8. Patients must have adequate liver and renal function.
9. Patients must have adequate bone marrow function.
10. Life expatancy of at least 3 months
11. 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
1. Patients who have received prior therapy with any taxane.
2. Patients whose primary site was the choroid (eye).
3. 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 treated for cure and with a disease-free survival
longer than 5 years.
4. Patients with symptomatic brain metastasis (es).
5. 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.
6. Patients with current active infections requiring anti-infectious treatment (e.g.,
antibiotics, antivirals, or antifungals).
7. Patients with current peripheral neuropathy of any etiology that is greater than
grade one (1).
8. Patients with unstable or serious concurrent medical conditions are excluded.
9. Patients with a known hypersensitivity to Cremophor.