Malignant MelanomaPhase 3NCT00087776
Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma
A Phase 3 study testing Taxoprexin and Dacarbazine in people with Malignant Melanoma, run by American Regent, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Taxoprexin and Dacarbazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 393 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2002to 27 Oct 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania, 19403
About this study
Official title: Phase III Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma
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.
Read the detailed description
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
- Conditions
- Malignant Melanoma
- Being tested
- Taxoprexin, Dacarbazine
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaxoprexinDrug
Also called Docosahexaenoic acid (DHA)-paclitaxel
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
DacarbazineDrug
Also called Imidazole carboxamide
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
| Study group | Role | What they receive |
|---|---|---|
| Taxoprexin | Experimental | Taxoprexin® 900 mg/m² intravenously every 3 weeks Receives: Drug: Taxoprexin |
| Dacarbazine | Active comparator | Dacarbazine 1000 mg/m² intravenously every 3 weeks. Receives: Drug: Dacarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 36 months
Secondary outcomes (4)
Percentage of Participants Who Achieved an Objective Complete Response or Partial Response
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.
Measured: Assessed every 6 weeks, up to 38 months
Duration of Response
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).
Measured: Assessed every 6 weeks, up to 36 months
Time to Progression (TPP)
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
Measured: Assessed every 6 weeks until progression or death, up to 36 months
Time to Failure (TTF)
Time to Failure (TTF) was defined as the time from the day of randomization to the discontinuation of protocol treatment for any reason.
Measured: Baseline to stopping treatment, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2004 (estimated)
- Study start6 Dec 2002
- Primary completion27 Oct 2007
- Study completion27 Oct 2007
Why it stopped: Interim analysis determined that the futility boundary had been crossed and there was no reasonable prospect that statistical significance would be achieved if patient accrual continued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087776
- Sponsor's protocol ID
- P01-02-17
- Status last verified
- Jan 2018
- First submitted
- 13 Jul 2004
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00087776
- Acronym / sponsor ID
- P01-02-17
- Conditions
- Malignant Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis determined that the futility boundary had been crossed and there was no reasonable prospect that statistical significance would be achieved if patient accrual continued
- Enrolment
- 393 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2002 (actual)
- Primary completion
- 27 Oct 2007 (actual)
- Study completion
- 27 Oct 2007 (actual)
- First posted
- 16 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taxoprexin | Experimental | Drug: TaxoprexinTaxoprexin® 900 mg/m² intravenously every 3 weeks |
| Dacarbazine | Active comparator | Drug: DacarbazineDacarbazine 1000 mg/m² intravenously every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TaxoprexinAlso: Docosahexaenoic acid (DHA)-paclitaxelAdministered 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 | Drug | Taxoprexin |
| DacarbazineAlso: Imidazole carboxamideAdministered 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 | Drug | Dacarbazine |
Primary outcome
Overall Participant Survival
Time frame: Up to 36 months
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.
4 secondary outcomes
Percentage of Participants Who Achieved an Objective Complete Response or Partial Response
Time frame: Assessed every 6 weeks, up to 38 months
Duration of Response
Time frame: Assessed every 6 weeks, up to 36 months
Time to Progression (TPP)
Time frame: Assessed every 6 weeks until progression or death, up to 36 months
Time to Failure (TTF)
Time frame: Baseline to stopping treatment, up to 36 months
Results and safety
The study was stopped early (reason given: Interim analysis determined that the futility boundary had been crossed and there was no reasonable prospect that statistical significance would be achieved if patient accrual continued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Taxoprexin and Dacarbazine in people with Malignant Melanoma, run by American Regent, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim analysis determined that the futility boundary had been crossed and there was no reasonable prospect that statistical significance would be achieved if patient accrual continued). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Participant Survival (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.