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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

NCT ID: NCT02223884

Last Updated: 2014-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malignant Melanoma

Keywords

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Malignant melanoma, second-line treatment, docetaxel, carboplatin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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weekly docetaxel and carboplatin

Group Type EXPERIMENTAL

docetaxel 35mg/m2

Intervention Type DRUG

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

Carboplatin AUC3

Intervention Type DRUG

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

Interventions

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docetaxel 35mg/m2

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

Intervention Type DRUG

Carboplatin AUC3

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2011-0300

Identifier Type: -

Identifier Source: org_study_id