Malignant Melanoma
Conditions
Keywords
Malignant melanoma, second-line treatment, docetaxel, carboplatin
Brief 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. 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.
Interventions
DRUGdocetaxel 35mg/m2
D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks
DRUGCarboplatin AUC3
D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | every 6 weeks, up to 4 year | Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed