Clinical trial NCT01259375: Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma
Official title: A Phase II Study of Amrubicin Chemotherapy as First Line Treatment in Patients With Metastatic or Unresectable Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Adult patients (age 18 years or older)
* Pathological diagnosis of soft tissue sarcoma. Pathology materials must be submitted and reviewed.
* Patients must have unresectable locally advanced or metastatic progressive disease prior to enrollment. Disease extent must be determined by scans (CT or PET CT) within 6 weeks of enrollment.
* No prior chemotherapy for soft tissue sarcoma.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function including the following:
* Adequate bone marrow reserve: absolute neutrophil count (segmented and bands) (ANC) 1.5 x 109/L, platelet count 100 x 109/L, and hemoglobin 90 g/L,
* Hepatic: bilirubin 1.5 x the upper limit of normal (ULN), ALT and AST 3.0 x ULN,
* Renal: serum creatinine 1.5 x ULN or calculated creatinine clearance greater than 60 mL/min,
* Cardiac: Left ventricular ejection fraction (LVEF) 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA);
* All labs must be done within 2 weeks prior to enrollment.
* Negative serum pregnancy test at the time of enrollment for females of childbearing potential;
* For males and females of child-producing potential, use of effective contraceptive methods during the study;
* Ability to understand the requirements of the study and provide written informed consent.

Exclusion Criteria:

* Pregnant or nursing females
* Chest radiotherapy with curative intent to the primary disease complex less than or equal to 28 days prior to first dose; cranial radiotherapy less than or equal to 21 days prior to first dose; radiotherapy to all other areas less than or equal to 7 days prior to first dose
* Concurrent severe or uncontrolled medical disease (eg, active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure, active viral hepatitis or chronic liver disease) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study
* Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable for 2 weeks after radiotherapy; if the patient is on corticosteroids, the dose of corticosteroids must have been stable for 2 weeks prior to first dose of study treatment, or be in the process of being tapered
* Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.
* Patients with known history of seropositive human immunodeficiency virus (HIV) or patients who are receiving immunosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications. HIV testing is not required for inclusion in the trial.
* Known hypersensitivity to any of the components of the i.v. formulation of amrubicin.
* Psychiatric disorder or any other personal circumstances that prevent compliance with the study protocol.
* Inability or unwillingness to comply with the study protocol.

Primary outcomes:
measure: Response Rate for Amrubicin in Patients With Metastatic or Advanced Sarcoma as First Line Therapy.
timeFrame: 48 months
measure: Progression Free Survival
timeFrame: six months
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events
timeFrame: 4 months
measure: Overall Survival
timeFrame: two years
measure: Quality of Response With Radiographic Evaluation Using Both Response Evaluation Criteria In Solid Tumors (RECIST) and Choi Criteria.
timeFrame: 48 months
measure: Differential Response to Amurbicin Among Certain Histologic Subtypes of Sarcoma.
timeFrame: 48 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Santa Monica
state: California
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
References: