NCT02223884
Completed
Phase 2
A Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Failed First-Line Dacabazine or Temozolomide Contained Therapy
ConditionsMalignant Melanoma
Overview
- Phase
- Phase 2
- Intervention
- docetaxel 35mg/m2
- Conditions
- Malignant Melanoma
- Sponsor
- Yonsei University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Response Rate
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
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
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
Arms & Interventions
weekly docetaxel and carboplatin
Intervention: docetaxel 35mg/m2
weekly docetaxel and carboplatin
Intervention: Carboplatin AUC3
Outcomes
Primary Outcomes
Response Rate
Time Frame: every 6 weeks, up to 4 year
Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI
Secondary Outcomes
- 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)
Study Sites (1)
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