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

NCT00087776 | Terminated Phase 3 FDA Drug

• 1 other identifier: P01-02-17
• Study Type: interventional
• Target: 393
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to compare the survival of patients with metastatic malignant melanoma treated with Taxoprexin Injection to those treated with Dacarbazine. In addition, the response rate to each drug, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• Overall Participant Survival

  Overall survival was defined as the time from the day of randomization to participant death or the termination of the study, whichever occurs first. Participants were contacted monthly for survival information.

  Up to 36 months

Secondary Outcomes (4)

• Percentage of Participants Who Achieved an Objective Complete Response or Partial Response

  Assessed every 6 weeks, up to 38 months

• Duration of Response

  Assessed every 6 weeks, up to 36 months

• Time to Progression (TPP)

  Assessed every 6 weeks until progression or death, up to 36 months

• Time to Failure (TTF)

  Baseline to stopping treatment, up to 36 months

Study Arms (2)

Taxoprexin

EXPERIMENTAL

Taxoprexin® 900 mg/m² intravenously every 3 weeks

Drug: Taxoprexin

Dacarbazine

ACTIVE COMPARATOR

Dacarbazine 1000 mg/m² intravenously every 3 weeks.

Drug: Dacarbazine

Interventions

Taxoprexin DRUG

Administered by intravenous infusion over 2 hour infusion on Day 1 followed by a 20-day observation period for a total of 21 days (three weeks) per course

Also known as: Docosahexaenoic acid (DHA)-paclitaxel

Taxoprexin

Dacarbazine DRUG

Administered by intravenous infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21 days (three weeks) per course

Also known as: Imidazole carboxamide

Dacarbazine

Eligibility Criteria

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

You may qualify if:

• 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 Eastern Cooperative Oncology Group 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 institution.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, 19403, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

docosahexaenoyl-paclitaxel; Docosahexaenoic Acids; Dacarbazine

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; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2004
• First Posted: July 16, 2004
• Study Start: December 6, 2002
• Primary Completion: October 27, 2007
• Study Completion: October 27, 2007
• Last Updated: July 23, 2025

Record last verified: 2018-01

Locations

US (1)