Rh-endostatin in Combination With Dacarbazine and Cisplatin as the First Line Therapy for Metastatic Melanoma

March 23, 2017 updated by: Jun Guo, Peking University Cancer Hospital & Institute

a Phase II Trial With Continuous Intravenous Infusion of Rh-endostatin in Combination With Dacarbazine and Cisplatin as the First Line Therapy for Metastatic Melanoma

The incidence of Melanoma is rapidly growthing,and in China,dacarbazine combined with cisplatin is conmendly used as the first-line chemotherapy of metastatic melanoma. But the response rate and survival results are very limited.This trial aim to add a safe and effective anti-angiogenesis drug,Human-recombinant endostatin,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Chuanliang Cui, MD
          • Phone Number: +86 13691489319

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Histologically confirmed melanoma with metastases and has no received any systemic treatment.
  • 2.At least one measurable site (diameter≥1cm) of disease (RECIST 1.1).
  • 3.Estimated life expectancy of 12 weeks or greater
  • 4. ECOG performance status 0, 1
  • 5.Adequate organ function
  • 6.Without symptoms of brain metastases and stable in neuro-functions

Exclusion Criteria:

  • 1. Pregnant or lactation women
  • 2. Acute infections without control.
  • 3. Heart disease history, cardiac function class≥NYHA II.
  • 4. HIV positive or chronic HBV/HCV in active stage.
  • 5. Brain metastases or primary tumor with positive symptoms
  • 6. Need anti-epileptic treatments
  • 7. Organ transplantation history
  • 8. Hemorrhagic tendency or related history
  • 9. Renal dialysis patients
  • 10. Diagnosis of any second malignancy within the last 3 years, except for adequately treated.
  • 11. Current treatment on another clinical trial
  • 12. The other improper situations which investigator judged.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EDP
Dacarbazine,DTIC： 250 mg/m2/d，IV, d1-5 Cisplatin PDD：75 mg/m2，IV Endostar ENDO：15 mg/m2/d，CIV,d1~14
Drug: recombinant human endostatin

Cisplatin:dose was based on patient's weight and could be adjusted for weight change,75 mg/m^2 by IV infusion separated in 3 different days Dacarbazine:250mg/m2,administered by intravenous (IV) infusion on the 1 to 5 day of each cycle

Hr-endostatin:dose based on body surface area as 15mg/m2,continuous intravenous infusion from day 1 to day 14

Other Names:
  • endostar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progress-free survival(PFS)
Time Frame: From randomization up to 144 weeks
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
From randomization up to 144 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate(DCR)
Time Frame: From randomization up to 144 weeks
CR+PR+SD
From randomization up to 144 weeks
adverse events
Time Frame: From randomization up to 144 weeks
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
From randomization up to 144 weeks

Collaborators and Investigators

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

Sponsor

Peking University Cancer Hospital & Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCH-MM-

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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