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Phase II Open-Label Study of Weekly Taxoprexin® (DHA-Paclitaxel) Injection as Treatment of Patients With Metastatic Uveal (Choroidal) Malignant Melanoma

Phase 2
13 Years
Not Enrolling
Metastatic Melanoma

Thank you

Trial Information

Phase II Open-Label Study of Weekly Taxoprexin® (DHA-Paclitaxel) Injection as Treatment of Patients With Metastatic Uveal (Choroidal) Malignant Melanoma

This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with
metastatic choroidal melanoma who may be previously untreated or have received one prior
systemic cytotoxic regimen for advanced disease. Patients may not have been treated
previously with taxanes. Patients may have been previously treated with immunological
agents including IL-2 and vaccines. Patients will receive Taxoprexin® Injection at a dose
of 500mg/m2 intravenously by 1-hour infusion weekly for the first five weeks of a six week
cycle. Treatment will continue until progression of disease, intolerable toxicity, refusal
of continued treatment by patient or Investigator decision.

Inclusion Criteria:

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


Exclusion Criteria:

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.


Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Principal Investigator

Agop Bedikian, MD

Investigator Role:

Study Director

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

April 2007

Related Keywords:

  • Metastatic Melanoma
  • Melanoma



MD Anderson Cancer Center Houston, Texas  77030-4096