Taxoprexin Treatment for Advanced Skin Melanoma

NCT00249262 | Completed Phase 2

• 1 other identifier: P01-04-21
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 malignant melanoma being treated with weekly Taxoprexin® Injection.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to Progression

  Assessed every 6 weeks until progression or death, up to 24 months

• Time to Treatment Failure

  Baseline to stopping treatment

• Overall Participant Survival

  Up to 24 months

Study Arms (1)

Taxoprexin

EXPERIMENTAL

Taxoprexin 500 mg/m² intravenously every week for 5 weeks

Drug: Taxoprexin

Interventions

Taxoprexin DRUG

Administered by intravenous infusion over 1 hour infusion weekly for the first five weeks of a six week cycle.

Also known as: Docosahexaenoic acid (DHA)-paclitaxel

Taxoprexin

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Regent, Inc.: lead

MeSH Terms

Conditions

Melanoma

Interventions

docosahexaenoyl-paclitaxel; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Mark A Falone, MD

  American Regent, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 7, 2005
• Study Start: October 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: September 26, 2025

Record last verified: 2018-01