Phase II Open-Label Study of Weekly Taxoprexin® (DHA-Paclitaxel) Injection as Treatment of Patients With Metastatic Uveal (Choroidal) Malignant Melanoma
1. Patients must have histologic or cytologic confirmation of malignant eye melanoma,
and documented metastatic disease.
2. Patients must have at least one unidimensionally measurable lesion.
3. Patients may be previously untreated or may have received one prior systemic
chemotherapy regimen for metastatic disease. Patients may not have been treated
previously with taxanes. Prior treatment with immunotherapy or vaccine therapy is
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. Lesions being used to assess disease status may not have been radiated or if so, must
have progressed during or after radiation therapy.
7. Patients must have ECOG performance status of 0 - 2.
8. Patients must be at least 13 years of age.
9. Patients must have adequate liver and renal function.
10. Patients must have adequate bone marrow function.
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 site of primary melanoma is not in 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.
10. Patients with Gilbert's Syndrome.
11. Patients must not have had major surgery within the past 14 days.
12. Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy
while on study.
13. Known HIV disease or infection.