Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Amrubicin

Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously

Primary Objectives

1. To evaluate the Response Rate (RR) for amrubicin in patients with metastatic or advanced sarcoma as first line therapy.
2. To evaluate Progression Free Survival (PFS).

Secondary Objectives

1. To assess the safety and tolerability of amrubicin in this patient population.
2. To evaluate whether certain histologic subtypes of sarcoma demonstrate a differential response to amrubicin.
3. To investigate quality of response with radiographic evaluation using both Response Evaluation Criteria In Solid Tumors (RECIST) and Choi criteria.
4. To evaluate overall survival (OS).

Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma

A Phase II Study of Amrubicin Chemotherapy as First Line Treatment in Patients With Metastatic or Unresectable Soft Tissue Sarcoma

Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.1) for target lesions and assessed by CT; time elapsed between treatment initiation and tumor progression or death. In target lesions, progression is defined per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In non-target lesions, progression is defined via RECIST v 1.1 as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

This variable reviews the percentage of Overall Survival at 24 months and presents the percentage of participants who survived at 2 years.

Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Exploratory CT evaluations according to Choi response criteria will be also performed and correlated with RECIST response.

Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

University of Utah

All participants enrolled.

Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously

All Patients

All Groups

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Sunil Sharma

One patient discontinued study treatment after the first cycle due to side effects and was not evaluable for response.

Response Rate for Amrubicin in Patients With Metastatic or Advanced Sarcoma as First Line Therapy.

All participants who received Amrubicin.

Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously

Progression Free Survival

One patient discontinued study treatment after the first cycle due to side effects and was not evaluable for response, but was evaluable for safety and toxicity.

Number of Participants With Serious Adverse Events

Overall Survival

This exploratory objective was not assessed.

Quality of Response With Radiographic Evaluation Using Both Response Evaluation Criteria In Solid Tumors (RECIST) and Choi Criteria.

liposarcoma

myxoid liposarcoma with TLS-CHOP translocation

leiomyoscarcoma

All patients who had a partial or greater response

Spots Global Cancer Trial Database for Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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