Phase 2
N=24
Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma
Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00949325 ↗Enrolled (actual)
24
Serious AEs
29.2%
Results posted
Mar 2019
Primary outcome: Primary: Part 1: Incidence of Dose Limiting Toxicities — 1; 4; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- temsirolimus plus liposomal doxorubicin (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Incidence of Dose Limiting Toxicities |
1; 4; 3 | — |
| PRIMARY Part 2: Median Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 |
254 | — |
| SECONDARY Median Progression-free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 |
74 | — |
| SECONDARY Objective Response Rate |
0; 1; 8; 5 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
346.2; 69.6 | — |
| SECONDARY Area Under the Curve (AUC) |
1210; 7499 | — |
| SECONDARY Drug Clearance |
17.8; NA | — |
| SECONDARY Mean Progression Free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 |
195 | — |
| SECONDARY Mean Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 |
632 | — |
| SECONDARY Time to Response |
— | — |
| SECONDARY Duration of Response |
— | — |
| SECONDARY Clinical Benefit Rate |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed sarcoma that is recurrent or refractory to conventional treatment
- Measurable disease by RECIST criteria
- ECOG (Eastern Cooperative Oncology Group) performance status 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 (aspartate aminotransferase) and ALT(alanine aminotransferase) 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 (prothrombin) or INR (international normalized ratio) 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
Data sourced from ClinicalTrials.gov (NCT00949325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.