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

NCT02223884 | Completed Phase 2

• 1 other identifier: 4-2011-0300
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Melanoma

Keywords

Malignant melanoma, second-line treatment, docetaxel, carboplatin

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI

  every 6 weeks, up to 4 year

Secondary Outcomes (4)

• 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

• adverse events

  every 6 weeks, up to 4 year

Study Arms (1)

weekly docetaxel and carboplatin

EXPERIMENTAL

Drug: docetaxel 35mg/m2; Drug: Carboplatin AUC3

Interventions

docetaxel 35mg/m2 DRUG

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

weekly docetaxel and carboplatin

Carboplatin AUC3 DRUG

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

weekly docetaxel and carboplatin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Melanoma

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2014
• First Posted: August 22, 2014
• Study Start: July 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

KR (1)