A Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Failed First-Line Dacabazine or Temozolomide Contained Therapy

Study Overview
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Brief Summary
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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
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Malignant Melanoma

Intervention / Treatment
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* Drug: docetaxel 35mg/m2
* Drug: Carboplatin AUC3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: 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 Uncontrolled seizure Women pregnant or nursing Alcohol or drug abuser

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: weekly docetaxel and carboplatin<br> | Drug: docetaxel 35mg/m2<br>* D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks<br>Drug: Carboplatin AUC3<br>* D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI | every 6 weeks, up to 4 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease control rate |  | every 6 weeks, up to 4 year | 
| progression free survival |  | every 6 weeks, up to 4 year | 
| overall survival |  | every 6 weeks, up to 4 year | 
| adverse events |  | every 6 weeks, up to 4 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant melanoma, second-line treatment, docetaxel, carboplatin