Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma (ARSARC-PI-0010)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Utah
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01259375
First received: December 10, 2010
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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).

Condition Intervention Phase
Soft Tissue Sarcoma
Drug: Amrubicin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Amrubicin Chemotherapy as First Line Treatment in Patients With Metastatic or Unresectable Soft Tissue Sarcoma

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • To evaluate the response rate for amrubicin in patients with metastatic or advanced sarcoma as first line therapy. [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    • To evaluate the response rate for amrubicin in patients with metastatic or advanced sarcoma as first line therapy.
    • To evaluate progression free survival.


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients
All participants enrolled.
Drug: Amrubicin
Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259375

Contacts
Contact: Justin Parker 801-587-4702 justin.parker@hci.utah.edu

Locations
United States, California
Santa Monica Recruiting
Santa Monica, California, United States, 90403
Contact: Sant P Chawla, MD    310-552-9999    santchawla@aol.com   
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Nicole Mauerman    801-581-5062    nicole.mauerman@hci.utah.edu   
Principal Investigator: Sunil Sharma, MD         
Sponsors and Collaborators
University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01259375     History of Changes
Other Study ID Numbers: HCI45197
Study First Received: December 10, 2010
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Amrubicin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014