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

NCT ID: NCT03095079

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-10-31

Brief Summary

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

recombinant human endostatin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

endostar

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Jun Guo

Director of department of renal cancer and melanoma Affiliation: Beijing Cancer Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chuanliang Cui, MD

Role: CONTACT

1008ccl@163.com

0086-10-88196951

Facility Contacts

Chuanliang Cui, MD

Role: primary

+86 13691489319

References

Cui C, Mao L, Chi Z, Si L, Sheng X, Kong Y, Li S, Lian B, Gu K, Tao M, Song X, Lin T, Ren X, Qin S, Guo J. A phase II, randomized, double-blind, placebo-controlled multicenter trial of Endostar in patients with metastatic melanoma. Mol Ther. 2013 Jul;21(7):1456-63. doi: 10.1038/mt.2013.79. Epub 2013 May 14.

Reference Type: RESULT

PMID: 23670576 (View on PubMed)

Other Identifiers

BCH-MM-

Identifier Type: -

Identifier Source: org_study_id