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

Malignant Melanoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223884
• Other study ID #: 4-2011-0300
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2014
• Last updated: August 27, 2014
• Start date: July 2011
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• docetaxel 35mg/m2
D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks
• Carboplatin AUC3
D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI	every 6 weeks, up to 4 year	Yes
Secondary	disease control rate		every 6 weeks, up to 4 year	Yes
Secondary	progression free survival		every 6 weeks, up to 4 year	No
Secondary	overall survival		every 6 weeks, up to 4 year	Yes
Secondary	adverse events		every 6 weeks, up to 4 year	Yes