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NCT00949325 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2019-03-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Part 1: Incidence of Dose Limiting Toxicities

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outcome · POSTED

Part 2: Median Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2

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outcome · POSTED

Median Progression-free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2

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outcome · POSTED

Objective Response Rate

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outcome · POSTED

Maximum Observed Plasma Concentration (Cmax)

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outcome · POSTED

Area Under the Curve (AUC)

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outcome · POSTED

Drug Clearance

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outcome · POSTED

Mean Progression Free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2

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outcome · POSTED

Mean Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2

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outcome · POSTED

Time to Response

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outcome · POSTED

Duration of Response

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outcome · POSTED

Clinical Benefit Rate

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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 \< 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 (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
healthy Volunteers
false
minimum Age
1 Year
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Single arm study: Dose escalation of temsirolimus plus constant dose of liposomal doxorubicin.
    intervention Names
    1. Drug: temsirolimus plus liposomal doxorubicin
    label
    temsirolimus plus liposomal doxorubicin
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. temsirolimus plus liposomal doxorubicin
    description
    Patients were treated with temsirolimus (Torisel) weekly by IV and with liposomal doxorubicin (Doxil) (standard dose) by IV once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until dose limiting toxicity (DLT) occurred and the maximally tolerated dose (MTD) was identified. The MTD dose was the standard dose of temsirolimus used for the remainder of the study. Dose modifications were based on protocol parameters for toxicities.
    name
    temsirolimus plus liposomal doxorubicin
    other Names
    1. Torisel
    2. Doxil
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
24
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Dose limiting toxicities in each dose cohort.
    measure
    Part 1: Incidence of Dose Limiting Toxicities
    time Frame
    End of second 28-day cycle
  2. description
    Number of days from day 1 of treatment until date of death from any cause.
    measure
    Part 2: Median Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2
    time Frame
    up to 5 years
secondary Outcomes
  1. description
    Interval from Date of start of treatment to date of disease progression or death from any cause. Disease progression is defined as at least 20% increase in sum of longest diameter of target lesions or appearance of any new lesions. Subjective determination of significant worsening of disease-related symptoms was considered clinical disease progression.
    measure
    Median Progression-free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2
    time Frame
    up to 3 years
  2. description
    Number of participants who completed at least 2 treatment cycles with evidence of response. Response is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression
    measure
    Objective Response Rate
    time Frame
    up to 5 years
  3. description
    Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS
    measure
    Maximum Observed Plasma Concentration (Cmax)
    time Frame
    Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4.
  4. description
    AUC was calculated using a single compartment model.
    measure
    Area Under the Curve (AUC)
    time Frame
    Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4.
  5. description
    Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS.
    measure
    Drug Clearance
    time Frame
    Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4.
  6. description
    Interval from start of treatment to disease progression or death from any cause. Disease progression is defined as at least 20% increase in sum of longest diameter of target lesions or appearance of any new lesions. Subjective determination of significant worsening of disease-related symptoms was considered clinical disease progression
    measure
    Mean Progression Free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2
    time Frame
    up to 3 years
  7. measure
    Mean Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2
    time Frame
    up to 5 years
  8. description
    Number of days after 2 cycles of treatment, until maximal response is observed.
    measure
    Time to Response
    time Frame
    up to 5 years
  9. description
    Number of days until documentation of disease progression or date of death from other cause
    measure
    Duration of Response
    time Frame
    up to 5 years
  10. description
    Number of days from documented improvement to disease progression.
    measure
    Clinical Benefit Rate
    time Frame
    up to 5 years
Full study description
brief 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.
detailed Description
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.
Source references
references
  1. citation
    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.
    pmid
    23382028
    type
    RESULT
  2. citation
    Trucco MM, Meyer CF, Thornton KA, Shah P, Chen AR, Wilky BA, Carrera-Haro MA, Boyer LC, Ferreira MF, Shafique U, Powell JD, Loeb DM. A phase II study of temsirolimus and liposomal doxorubicin for patients with recurrent and refractory bone and soft tissue sarcomas. Clin Sarcoma Res. 2018 Nov 5;8:21. doi: 10.1186/s13569-018-0107-9. eCollection 2018.
    pmid
    30410720
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice