Back to resultsA Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Failed First-Line Dacabazine or Temozolomide Contained Therapy
Primary Purpose
Malignant Melanoma
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
docetaxel 35mg/m2
Carboplatin AUC3
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Melanoma focused on measuring Malignant melanoma, second-line treatment, docetaxel, carboplatin
Eligibility Criteria
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
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
weekly docetaxel and carboplatin
Arm Description
Outcomes
Primary Outcome Measures
Response Rate
Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI
Secondary Outcome Measures
disease control rate
progression free survival
overall survival
adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02223884
Brief Title
A Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Failed First-Line Dacabazine or Temozolomide Contained Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
Keywords
Malignant melanoma, second-line treatment, docetaxel, carboplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
weekly docetaxel and carboplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
docetaxel 35mg/m2
Intervention Description
D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Carboplatin AUC3
Intervention Description
D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks
Primary Outcome Measure Information:
Title
Response Rate
Description
Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI
Time Frame
every 6 weeks, up to 4 year
Secondary Outcome Measure Information:
Title
disease control rate
Time Frame
every 6 weeks, up to 4 year
Title
progression free survival
Time Frame
every 6 weeks, up to 4 year
Title
overall survival
Time Frame
every 6 weeks, up to 4 year
Title
adverse events
Time Frame
every 6 weeks, up to 4 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Failed First-Line Dacabazine or Temozolomide Contained Therapy
We'll reach out to this number within 24 hrs