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

18 Years
Not Enrolling
Malignant Melanoma

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Trial Information

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

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 ECOG 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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

October 2002

Completion Date:

Related Keywords:

  • Malignant Melanoma
  • Melanoma



Luitpold Pharmaceuticals, Inc. Norristown, Pennsylvania  19403