Status:
COMPLETED
Taxoprexin Treatment for Advanced Skin Melanoma
Lead Sponsor:
American Regent, Inc.
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief Summary
To evaluate objective response rate and duration of response to weekly Taxoprexin®. To evaluate the safety profile of weekly Taxoprexin® in this patient population. To evaluate overall survival in t...
Detailed Description
This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with metastatic malignant melanoma who have not received cytotoxic agents for advanced disease. Patients may have been p...
Eligibility Criteria
Inclusion
- Patients must have malignant skin/mucosal (non-choroidal) melanoma, and documented metastatic disease.
- Patients must have at least one measurable lesion.
- Patients must not have received prior systemic chemotherapy for metastatic disease. Prior treatment with immunotherapy or vaccine therapy is allowed.
- At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy.
- At least 4 weeks (28 days) since prior radiotherapy to \> 20% of the bone marrow and prior adjuvant chemotherapy.
- Patients must have Eastern Cooperative Oncology Group performance status of 0-2.
- Patients must be \> 13 years of age. The safety of Taxoprexin has not been adequately studied in younger patients.
- Patients must have adequate liver and renal 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
- Patients who have received prior therapy with any taxane.
- Patients whose primary site was the choroid (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 treated for cure and with a disease-free survival longer than 5 years.
- Patients with symptomatic brain metastasis (es).
- 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 one (1).
- Patients with unstable or serious concurrent medical conditions are excluded.
- Patients with a known hypersensitivity to Cremophor.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00249262
Start Date
October 1 2005
End Date
April 1 2007
Last Update
September 26 2025
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