Malignant MelanomaPhase 2NCT02223884
A Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Failed First-Line Dacabazine or Temozolomide Contained Therapy
A Phase 2 study testing docetaxel 35mg/m2 and Carboplatin AUC3 in people with Malignant Melanoma, run by Yonsei University at 1 site in South Korea.
Trial summary
This is the phase II, single-arm, single-center study assessing the efficacy of weekly docetaxel plus carboplatin in second-line treatment of malignant melanoma (unresectable or metastatic) who has failed dacarbazine or temozolomide contained therapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- docetaxel 35mg/m2 and Carboplatin AUC3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Aug 2014
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven malignant melanoma (recurred or metastatic) that had progressed during or after receiving at least one cycle of a regimen containing dacarbazine or temozolomide in the advanced setting
- Measurable disease (RECIST)
- ECOG performance 0-2
- Adequate organ function
- Total bilirubin <1.5N ; ASAT and ALAT <2.5N
- Serum Creatinin < 1.5N
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- ANC ≥ 1,500/mm³ (G-CSF allowed)
- Platelets ≥ 100,000/mm³
- Hb ≥ 9.0 g/dL
- Life expectancy of at least 12 weeks
- Signed Written Informed Consent
Who cannot join
- Symptomatic brain metastasis
- Previous history of treatment with taxane or platinum agent containing chemotherapy
- Previous major surgery within 2 weeks before the start of the trial, or a failure to recover from the surgery
- Previous history of other malignancies within 5 years except for cured skin basal cell carcinoma or cured in-situ cervix cancer
- Other severe medical conditions (infection, uncontrolled hypertension, heart failure, MI history within 6 months)
- Sensitivity to platinum agents or docetaxel
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- Uncontrolled seizure
- Women pregnant or nursing
- Alcohol or drug abuser
Trial locations and contacts
1 site in 1 country.
About this study
This is the phase II, single-arm, single-center study assessing the efficacy of weekly docetaxel plus carboplatin in second-line treatment of malignant melanoma (unresectable or metastatic) who has failed dacarbazine or temozolomide contained therapy. The primary end point is overall response rate according to RECIST 1.1 criteria assessed using CT or MRI and secondary end point includes disease control rate, progression free survival, overall survival and safety.
- Conditions
- Malignant Melanoma
- Being tested
- docetaxel 35mg/m2, Carboplatin AUC3
- Keywords
- Malignant melanoma, second-line treatment, docetaxel, carboplatin
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel 35mg/m2Drug
D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks
Carboplatin AUC3Drug
D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| weekly docetaxel and carboplatin | Experimental | Not described Receives: Drug: docetaxel 35mg/m2; Drug: Carboplatin AUC3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI
Measured: every 6 weeks, up to 4 year
Secondary outcomes (4)
disease control rate
Measured: every 6 weeks, up to 4 year
progression free survival
Measured: every 6 weeks, up to 4 year
overall survival
Measured: every 6 weeks, up to 4 year
adverse events
Measured: every 6 weeks, up to 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startJul 2011
- Primary completionAug 2014
- Study completionAug 2014
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.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223884
- Sponsor's protocol ID
- 4-2011-0300
- Status last verified
- Aug 2014
- First submitted
- 17 Aug 2014
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Failed First-Line Dacabazine or Temozolomide Contained Therapy
- ClinicalTrials.gov ID
- NCT02223884
- Acronym / sponsor ID
- 4-2011-0300
- Conditions
- Malignant Melanoma
- Keywords
- Malignant melanoma, second-line treatment, docetaxel, carboplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Aug 2014 (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.
This is the phase II, single-arm, single-center study assessing the efficacy of weekly docetaxel plus carboplatin in second-line treatment of malignant melanoma (unresectable or metastatic) who has failed dacarbazine or temozolomide contained therapy. The primary end point is overall response rate according to RECIST 1.1 criteria assessed using CT or MRI and secondary end point includes disease control rate, progression free survival, overall survival and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| weekly docetaxel and carboplatin | Experimental | Drug: docetaxel 35mg/m2, Drug: Carboplatin AUC3 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histologically proven malignant melanoma (recurred or metastatic) that had progressed during or after receiving at least one cycle of a regimen containing dacarbazine or temozolomide in the advanced setting
- Measurable disease (RECIST)
- ECOG performance 0-2
- Adequate organ function
- Total bilirubin <1.5N ; ASAT and ALAT <2.5N
Key exclusion criteria (9 listed)
- Symptomatic brain metastasis
- Previous history of treatment with taxane or platinum agent containing chemotherapy
- Previous major surgery within 2 weeks before the start of the trial, or a failure to recover from the surgery
- Previous history of other malignancies within 5 years except for cured skin basal cell carcinoma or cured in-situ cervix cancer
- Other severe medical conditions (infection, uncontrolled hypertension, heart failure, MI history within 6 months)
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 |
|---|---|---|
| docetaxel 35mg/m2D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks | Drug | weekly docetaxel and carboplatin |
| Carboplatin AUC3D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks | Drug | weekly docetaxel and carboplatin |
Primary outcome
Response Rate
Time frame: every 6 weeks, up to 4 year
Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI
4 secondary outcomes
disease control rate
Time frame: every 6 weeks, up to 4 year
progression free survival
Time frame: every 6 weeks, up to 4 year
overall survival
Time frame: every 6 weeks, up to 4 year
adverse events
Time frame: every 6 weeks, up to 4 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
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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 2 study testing docetaxel 35mg/m2 and Carboplatin AUC3 in people with Malignant Melanoma, run by Yonsei University at 1 site in South Korea.
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 11 inclusion and 9 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: finished, as of the sponsor's last update on 29 Aug 2014. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response Rate (time frame: every 6 weeks, up to 4 year). 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 29 Aug 2014.