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

August 27, 2014 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: every 6 weeks, up to 4 year
Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI
every 6 weeks, up to 4 year

Secondary Outcome Measures

Outcome Measure
Time Frame
disease control rate
Time Frame: every 6 weeks, up to 4 year
every 6 weeks, up to 4 year
progression free survival
Time Frame: every 6 weeks, up to 4 year
every 6 weeks, up to 4 year
overall survival
Time Frame: every 6 weeks, up to 4 year
every 6 weeks, up to 4 year
adverse events
Time Frame: every 6 weeks, up to 4 year
every 6 weeks, up to 4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

August 17, 2014

First Submitted That Met QC Criteria

August 20, 2014

First Posted (ESTIMATE)

August 22, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 27, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2011-0300

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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