Taxoprexin® Treatment for Advanced Eye Melanoma

NCT ID: NCT00244816

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2008-06-30

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 the same patient population. To evaluate time to disease progression, and the time to treatment failure in patients with metastatic choroidal melanoma being treated with weekly Taxoprexin® Injection.

Detailed Description

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 interleukin-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.

Conditions

Metastatic Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Taxoprexin

Taxoprexin 500 mg/m² intravenously every week

Group Type: EXPERIMENTAL

Taxoprexin

Intervention Type: DRUG

Administered by intravenous infusion over 1 hour infusion for 5 consecutive weeks in a 6-weeks cycle.

Interventions

Taxoprexin

Administered by intravenous infusion over 1 hour infusion for 5 consecutive weeks in a 6-weeks cycle.

Intervention Type: DRUG

Other Intervention Names

Docosahexaenoic acid (DHA)-paclitaxel

Eligibility Criteria

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 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. 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 Eastern Cooperative Oncology Group 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 institution.

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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.

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• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Regent, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark A Falone, MD

Role: STUDY_DIRECTOR

American Regent, Inc.

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

P01-04-22

Identifier Type: -

Identifier Source: org_study_id