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

• Status: Withdrawn
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborators: Beijing Jishuitan Hospital; Chinese PLA General Hospital; Peking Union Medical College Hospital; Peking University Shougang Hospital; Xijing Hospital
• Treatments: Doxorubicin; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin; Pirarubicin

Criteria

Inclusion Criteria:

• 16 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.

Exclusion Criteria:

• 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.