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Completed

NCT Number: NCT02223884

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

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.

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel 35mg/m2

Drug

D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks

Carboplatin AUC3

Drug

D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 22, 2014
Registry last updated
Aug 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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