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

Phase 2

Completed

• Conditions: Malignant Melanoma
• Interventions: Drug: docetaxel 35mg/m2; Drug: Carboplatin AUC3

• Registration Number: NCT02223884
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted: 2014-08-17
• Study First Submitted QC: 2014-08-20
• Study First Posted: 2014-08-22
• Last Update Submitted: 2014-08-27
• Last Update Posted: 2014-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
weekly docetaxel and carboplatin	docetaxel 35mg/m2	-
weekly docetaxel and carboplatin	Carboplatin AUC3	-

Primary Outcome Measures

Name	Time	Method
Response Rate	every 6 weeks, up to 4 year	Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI

Secondary Outcome Measures

Name	Time	Method
adverse events	every 6 weeks, up to 4 year
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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of