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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):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00949325
First received: July 28, 2009
Last updated: June 23, 2014
Last verified: June 2014

July 28, 2009
June 23, 2014
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 ]
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 ]
  • objective response rate [ Time Frame: 2-4 months ] [ Designated as safety issue: Yes ]
  • 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 ]
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
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
Temsirolimus is administered IV at a dose between 15 and 50 mg/M2, once weekly. Liposomal doxorubicin is administered IV at a dose of 30 mg per M2 (body surface area) once every 28 days. Treatment may continue with both drugs for 2 years. Treatment with Temsirolimus may continue beyond 2 years.
Intervention: Drug: temsirolimus (Torisel) plus liposomal doxorubicin (Doxil)
Thornton KA, Chen AR, Trucco MM, Shah P, Wilky BA, Gul N, Carrera-Haro MA, Ferreira MF, Shafique U, Powell JD, Meyer CF, Loeb DM. A dose-finding study of temsirolimus and liposomal doxorubicin for patients with recurrent and refractory bone and soft tissue sarcoma. Int J Cancer. 2013 Aug 15;133(4):997-1005. doi: 10.1002/ijc.28083. Epub 2013 Mar 4.

*   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
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
June 2014

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