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

Yonsei University

Status and phase: Completed; Phase 2

Conditions: Malignant Melanoma

Treatments: Drug: docetaxel 35mg/m2; Drug: Carboplatin AUC3

Study type: Interventional

Funder types: Other

Identifiers

NCT02223884

4-2011-0300

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

weekly docetaxel and carboplatin

Experimental group

Treatment:

Drug: docetaxel 35mg/m2

Drug: Carboplatin AUC3