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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02223884
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Drug: docetaxel 35mg/m2 Drug: Carboplatin AUC3 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: weekly docetaxel and carboplatin Drug: docetaxel 35mg/m2
D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. disease control rate [ Time Frame: every 6 weeks, up to 4 year ]
  2. progression free survival [ Time Frame: every 6 weeks, up to 4 year ]
  3. overall survival [ Time Frame: every 6 weeks, up to 4 year ]
  4. adverse events [ Time Frame: every 6 weeks, up to 4 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223884


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02223884    
Other Study ID Numbers: 4-2011-0300
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014
Keywords provided by Yonsei University:
Malignant melanoma, second-line treatment, docetaxel, carboplatin
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Carboplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action