Taxoprexin Treatment for Advanced Skin Melanoma

Phase II Open-Label Study of Weekly Taxoprexin (DHA-paclitaxel) Injection as First Line Treatment of Patients With Metastatic Non-choroidal Melanoma

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 malignant melanoma being treated with weekly Taxoprexin® Injection.

Study Overview

• Status: Completed
• Conditions: Metastatic Melanoma
• Intervention / Treatment: Drug: Taxoprexin

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 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients must have malignant skin/mucosal (non-choroidal) melanoma, and documented metastatic disease.
2. Patients must have at least one measurable lesion.
3. Patients must not have received prior systemic chemotherapy for metastatic disease. 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. Patients must have Eastern Cooperative Oncology Group performance status of 0-2.
7. Patients must be > 13 years of age. The safety of Taxoprexin has not been adequately studied in younger patients.
8. Patients must have adequate liver and renal function.
9. Patients must have adequate bone marrow function.
10. Life expectancy of at least 3 months
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.

Exclusion Criteria:

1. Patients who have received prior therapy with any taxane.
2. Patients whose primary site was 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Taxoprexin; Taxoprexin 500 mg/m² intravenously every week for 5 weeks	Drug: Taxoprexin; Administered by intravenous infusion over 1 hour infusion weekly for the first five weeks of a six week cycle.; Other Names: Docosahexaenoic acid (DHA)-paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved an Objective Complete Response (CR) or Partial Response (PR).	Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial response was defined as a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum of LD determined by 2 consecutive observations not less than 4 weeks apart.	Assessed every 6 weeks, up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Progression	Progression free survival time was defined as the time from the day of randomization to the start of documented progression, based on the blinded radiological review response assessment. Progressive disease was defined as a ≥ 20% increase in the sum of longest diameter (SLD) of target lesions, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions.	Assessed every 6 weeks until progression or death, up to 24 months
Time to Treatment Failure	Time to Failure was defined as the time from the day of randomization to the discontinuation of protocol treatment for any reason.	Baseline to stopping treatment
Overall Participant Survival	Overall survival was defined as the time from the day of randomization to participant death or last date that participant was known to be alive, whichever occurs first. Survival data was collected every two months while participants were off-study.	Up to 24 months

Collaborators and Investigators

• Sponsor: American Regent, Inc.
• Investigators: Study Director: Mark A Falone, MD, American Regent, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: November 3, 2005
• First Submitted That Met QC Criteria: November 3, 2005
• First Posted (Estimated): November 7, 2005

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Fatty Acids; Lipids; Fatty Acids, Unsaturated; Oils; Dietary Fats; Fats; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Fish Oils; Docosahexaenoic Acids; docosahexaenoyl-paclitaxel
• Other Study ID Numbers: P01-04-21