Suspended

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

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What is being tested

Taxoprexin

+ Dacarbazine
Drug
Who is being recruted

Malignant Melanoma

Over 18 Years
+22 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: December 2002

See protocol details

Summary

Principal SponsorAmerican Regent, Inc.
Last updated: July 23, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: December 6, 2002Actual date on which the first participant was enrolled.

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. This was a randomized, multi-center, open-label Phase III study in patients with histologically confirmed metastatic malignant melanoma. Patients received either Taxoprexin® at a starting dose of 900 mg/m2 intravenously by 2-hour infusion on Day 1 every 3 weeks or dacarbazine at a starting dose of 1000 mg/m2 intravenously over at least 30 minutes once every 3 weeks. Treatment continued until progression of disease, intolerable toxicity, refusal of continued treatment by the patient, or, in the investigator's opinion, treatment discontinued. Disease status was assessed every 6 to 8 weeks using standard imaging techniques. All images were forwarded to the sponsor and archived. Following the end of protocol treatment, further treatment was at the investigator's discretion but no cross-over was planned. All patients were followed until death

Official TitlePhase III Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma 
Principal SponsorAmerican Regent, Inc.
Last updated: July 23, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
393 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Malignant Melanoma
Criteria
12 inclusion criteria required to participate
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

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10 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Taxoprexin® 900 mg/m² intravenously every 3 weeks
Group II
Active Comparator
Dacarbazine 1000 mg/m² intravenously every 3 weeks.
Study Objectives
Primary Objectives

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.
Secondary Objectives

Time to Failure (TTF) was defined as the time from the day of randomization to the discontinuation of protocol treatment for any reason.

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.

Duration of overall response was a measurement from the time measure criteria was met for confirmed complete response or partial response (whichever was first recorded) until the first date that recurrent of progressive disease was objectively documented (taking as reference for progressive disease the smallest measurement recorded since treatment started).

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Luitpold Pharmaceuticals, Inc.Norristown, United StatesSee the location
SuspendedOne Study Center