Pegylated Liposomal Doxorubicin Versus Pirarubicin Plus Ifosfamide, Dacarbazine in Locally Advanced, Unresectable or Metastatic Soft-tissue Sarcoma

NCT03342300 | Withdrawn Phase 2 DMC

• 1 other identifier: CBTRA-03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Advanced soft tissue sarcoma patients who have previously recieved anthracyclines might still benefit from doxorubicin, ifosfamide and dacarbazine. However doxorubicin might be stopped using because of chronic cumulative heart toxicity. Several efforts have been made to improve the toxicity profile of conventional anthracyclines, including the use of liposomal encapsulation technology and the development of novel anthracycline analogs,such as pegylated liposomal doxorubicin and pirarubicin. However their actual effectiveness and toxicity have not been studied in prospective trial. The purpose of the study is to investigate whether they are available for this group of patients.

Conditions

Progression-free Survival; Overall Survival; Toxicity

Keywords

soft tissue sarcoma; pegylated liposomal doxorubicin; pirarubicin; toxicity for heart; cumulative dose

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  Progression-free survival is defined as time from randomisation to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment or randomisation.

  12 weeks

Secondary Outcomes (3)

• overall survival

  12 months

• objective response rate, ORR

  12 weeks

• left ventricular ejection fraction function

  12 months

Study Arms (2)

Arm A

EXPERIMENTAL

participants will recieve pegylated liposomal doxorubicin (50 mg/m²d1) plus ifosfamide (2 g/m²/d d2-3), dacarbazine (300 mg/m²/d d2-3).

Drug: pegylated liposomal doxorubicin

Arm B

PLACEBO COMPARATOR

participants will recieve pirarubicin (60 mg/m²d1) plus ifosfamide (2 g/m²/d d2-3), dacarbazine (300 mg/m²/d d2-3).

Drug: pirarubicin

Interventions

pegylated liposomal doxorubicin DRUG

Several efforts have been made to improve the toxicity profile of conventional anthracyclines, including the use of liposomal encapsulation technology,such as pegylated liposomal doxorubicin.

Arm A

pirarubicin DRUG

Another effort has been made to improve the toxicity profile of conventional anthracyclines is the development of novel anthracycline analogs,such as pirarubicin.

Arm B

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older;
• diagnosis of an advanced unresectable or metastatic soft tissue sarcoma, of intermediate or high grade, for which no standard curative therapy is available;
• cumulative dose of anthracycline antibiotic ≥ 300mg/m2;
• stable or responsive to doxorubicin, potential beneficiary;
• an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, a life expectancy of at least 3 months;
• measurable disease according to RECIST 1.1;
• adequate end-organ and haemopoietic function.

You may not qualify if:

• progress over doxorubicin;
• previous mediastinal or cardiac radiotherapy;
• a low-grade tumour according to standard grading systems (eg, American Joint Committee on Cancer grade 1 and 2 or Fédération Nationale des Centres de Lutte Contre le Cancer grade 1);
• significant cardiac dysfunction;
• severe chronic obstructive pulmonary disease;
• a known infection with HIV or active infection with hepatitis B or hepatitis C;
• known brain metastases unless previously treated and well controlled for a period of 3 months or longer;
• combination with other anti-tumor therapy;
• pregnant or breastfeeding.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Peking University Shougang Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Beijing Jishuitan Hospital: collaborator
• Xijing Hospital: collaborator
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

Related Publications (17)

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MeSH Terms

Conditions

Sarcoma

Interventions

liposomal doxorubicin; pirarubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Wei Guo, M.D.and Ph.D.

  Musculoskeletal Tumor Center of Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A web-based central randomisation with block sizes of two and four was stratified by extent of disease,anthracycline administration method, and previous systemic therapy. Participants and investigators will not be masked to treatment assignment. The primary endpoint will be assessed in the intention-to-treat population. The outcome assessors will be masked to the two research groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned (1:1) to receive pegylated liposomal doxorubicin (50 mg/m² on day 1 of every 21-day cycle for up to six cycles) or pirarubicin (60 mg/m² on day 1 of every 21-day cycle for up to six cycles) plus ifosfamide (2 g/m²/d d2-4 of every 21-day cycle for up to six cycles) and dacarbazine (300 mg/m²/d d2-4 of every 21-day cycle for up to six cycles).

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 14, 2017
• Study Start: November 6, 2017
• Primary Completion: November 15, 2020
• Study Completion: December 30, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR

Locations

CN (1)