Clinical trial · Interventional
A Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Failed First-Line Dacabazine or Temozolomide Contained Therapy
NCT02223884CI-TRIAL-00015498completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin AUC3 | Drug | — | UNRESOLVED |
| docetaxel 35mg/m2 | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- weekly docetaxel and carboplatin
- interventionNames
- Drug: docetaxel 35mg/m2
- Drug: Carboplatin AUC3
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- every 6 weeks, up to 4 year
- description
- Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI
Secondary outcomes (4)
- measure
- disease control rate
- timeFrame
- every 6 weeks, up to 4 year
- measure
- progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.