Status:
COMPLETED
A Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Failed First-Line Dacabazine or Temozolomide Contained Therapy
Lead Sponsor:
Yonsei University
Conditions:
Malignant Melanoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 fa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02223884
Start Date
July 1 2011
End Date
August 1 2014
Last Update
August 29 2014
Active Locations (1)
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1
Severance Hospital
Seoul, Seoul, South Korea, 120-752