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Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma

This study has been completed.
Sponsor:
Collaborators:
National Comprehensive Cancer Network
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
David Loeb, Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00949325
First received: July 28, 2009
Last updated: September 24, 2012
Last verified: September 2012
History of Changes

July 28, 2009
September 24, 2012
September 2009
September 2012   (final data collection date for primary outcome measure)
  • Incidence of dose limiting toxicities [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Objective response rate [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00949325 on ClinicalTrials.gov Archive Site
  • To describe the pharmacokinetics of Torisel when administered with liposomal doxorubicin [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
  • Clinical benefit rate [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To assess the activity of the mTOR signaling pathway before and after therapy with Torisel and liposomal doxorubicin [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • To measure the proportion of cells with stem cell properties in tumors before and after treatment with Torisel and liposomal doxorubicin [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma
Phase I/II Trial of Torisel and Liposomal Doxorubicin in Patients With Advanced Soft Tissue and Bone Sarcomas

The purpose of this study is to identify a safe dosing regimen for the combination of Torisel and liposomal doxorubicin in patients with recurrent sarcoma. A secondary purpose of the study is to determine how effective this combination is for the treatment of recurrent sarcoma.

The effectiveness of treatments for recurrent sarcomas is quite limited. One hypothesis to explain the refractory nature of recurrent sarcomas is the existence of chemotherapy-resistant sarcoma stem cells.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma
Drug: temsirolimus (Torisel) plus liposomal doxorubicin (Doxil)
Patients will be treated with temsirolimus weekly by iv and with liposomal doxorubicin by iv every 28 days. Initial dosing will be with standard doses for each drug, but dosing will be modified based on toxicity.
Other Names:
  • Torisel
  • Doxil
Experimental: Temsirolimus plus Liposomal Doxorubicin
Intervention: Drug: temsirolimus (Torisel) plus liposomal doxorubicin (Doxil)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed sarcoma that is recurrent or refractory to conventional treatment
  • Measurable disease by RECIST criteria
  • ECOG performance status < 2 (or Lansky/Karnofsky > 60% for children)
  • Life expectancy greater than 3 months
  • Adequate organ function
  • absolute neutrophil count at least 1,500
  • platelets at least 100,000
  • bilirubin less than 1.5 x upper limit of normal
  • AST and ALT less than 2.5 x upper limit of normal
  • creatinine less than 1.5 x upper limit of normal OR creatinine clearance at least 60 ml/min/1.73 m2
  • fasting serum cholesterol less than 350
  • fasting serum triglycerides less than 400
  • PT or INR less than 1.3 x upper limit of normal
  • normal urinalysis
  • Ability to understand and sign the informed consent document

Exclusion Criteria:

  • Prior chemotherapy or radiotherapy within 3 weeks of entering the study (6 weeks for nitrosoureas or mitomycin C)
  • Prior treatment with a tyrosine kinase inhibitor within 10 days of entering the study
  • History of pulmonary hypertension or pneumonitis
  • Patients may not be receiving other investigational agents
  • Prior therapy with rapamycin, rapamycin analogues, or tacrolimus
  • Uncontrolled brain metastases
  • History of grade 3 or 4 hypersensitivity to macrolide antibiotics
  • Concurrent treatment with immunosuppressive agents other than a stable (for more than 2 weeks) dose of corticosteroids
  • Uncontrolled intercurrent illness
  • Pregnancy or breast feeding
  • HIV-positive patients on combination antiretroviral therapy
  • Grade 3 or 4 proteinuria
Both
1 Year and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00949325
J0963, NA_00028490
No
David Loeb, Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
  • National Comprehensive Cancer Network
  • Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: David M Loeb, MD, PhD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP