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A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma

Primary Purpose

Soft Tissue Sarcoma, Sarcoma, Neoplasms, Connective and Soft Tissue

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Doxorubicin
Trabectedin
Dexamethasone
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring Doxorubicin, Adriamycin, Trabectedin, Yondelis, Ecteinascidin 743, Filgrastim, Antineoplastic, Antineoplastic Agents, Pharmacologic Actions, Alkylating Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Have a diagnosis of soft tissue sarcoma, recurrent or persistent Signed informed consent obtained for all patients before performing any study-related procedures Exclusion Criteria: Patients treated with more than 1 prior chemotherapy regimen (including adjuvant (or other additional) therapy) Previous exposure to anthracyclines (a class of drugs used in cancer chemotherapy, example is Doxorubicin) or trabectedin Less than 4 weeks since radiation therapy Known metastases (spread) of cancer to the central nervous system Other ongoing serious illness present at the time of enrollment as determined by the Investigator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Trabectedin and doxorubicin

    Arm Description

    Doxorubicin (50 to 75 mg/m2) administered intravenously on Day 1 followed by trabectedin (0.9 to 1.3 mg/m2) administered intravenously on Day 1 every 3 weeks for up to 6 cycles. Dexamethasone 20 mg administered intravenously will be given within 1 hour before the start of doxorubicin. Patients may receive filgrastim for unmanageable neutropenia.

    Outcomes

    Primary Outcome Measures

    Number of patients with adverse events as a measure of safety

    Secondary Outcome Measures

    The number of patients with clinically relevant changes in clinically laboratory tests
    Number of patients with neutropenia
    Plasma concentrations of trabectedin (Yondelis)
    Plasma concentrations of Doxorubicin
    Plasma concentrations of Doxorubicinol

    Full Information

    First Posted
    January 31, 2005
    Last Updated
    January 9, 2013
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    PharmaMar, PharmaMar S.A.U.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00102609
    Brief Title
    A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma
    Official Title
    A Phase I Study to Determine the Dose of the Combination of Yondelis and Doxorubicin for Which Neutropenia is Manageable With the Support of Granulocyte-Colony Stimulation Factor in Subjects With Recurrent or Persistent Soft Tissue Sarcoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    PharmaMar, PharmaMar S.A.U.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be managed with filgrastim (a Granulocyte-Colony Stimulation Factor that is used to help control neutropenia) in patients with a type of cancer called soft tissue sarcoma.
    Detailed Description
    This is a multicenter, open-label (identity of the assigned study treatments will be known to patients and study staff) study to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which the neutropenia (low white blood cell counts) is manageable with the use of filgrastim (an agent used to manage neutropenia) and associated with clinically acceptable number of side effects severe enough to continuation of treatment in patients with recurrent or persistent soft tissue sarcoma (STS, a malignant tumor that attacks the body's infrastructure of fat, muscles, nerves, joints, blood vessels, or deep skin tissues). Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Doxorubicin (50 to 75 mg/m2) will be given as a 10-15 minute intravenous (i.v.) infusion on Day 1 via a central venous catheter which is a tube placed into a large vein. Trabectedin (0.9 to 1.3 mg/m2) will be given as a 3 hour i.v. infusion, immediately following the administration of doxorubicin. Dexamethasone 20 mg will be given within 1 hour before the start of each doxorubicin i.v. infusion and filgrastim will be administered according to manufacturer's instructions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Soft Tissue Sarcoma, Sarcoma, Neoplasms, Connective and Soft Tissue, Neoplasms by Histologic Type, Neoplasms
    Keywords
    Doxorubicin, Adriamycin, Trabectedin, Yondelis, Ecteinascidin 743, Filgrastim, Antineoplastic, Antineoplastic Agents, Pharmacologic Actions, Alkylating Agents

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    41 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Trabectedin and doxorubicin
    Arm Type
    Experimental
    Arm Description
    Doxorubicin (50 to 75 mg/m2) administered intravenously on Day 1 followed by trabectedin (0.9 to 1.3 mg/m2) administered intravenously on Day 1 every 3 weeks for up to 6 cycles. Dexamethasone 20 mg administered intravenously will be given within 1 hour before the start of doxorubicin. Patients may receive filgrastim for unmanageable neutropenia.
    Intervention Type
    Drug
    Intervention Name(s)
    Doxorubicin
    Intervention Description
    Doxorubicin 50 to 75 mg/m2 administered intravenously on Day 1
    Intervention Type
    Drug
    Intervention Name(s)
    Trabectedin
    Intervention Description
    Trabectedin 0.9 to 1.3 mg/m2 administered intravenously on Day 1 every 3 weeks for up to 6 cycles
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    Dexamethasone 20 mg administered intravenously within 1 hour before the start of doxorubicin
    Primary Outcome Measure Information:
    Title
    Number of patients with adverse events as a measure of safety
    Time Frame
    Up to approximately 19 weeks (six 3-week treatment cycles+30 day safety follow up)
    Secondary Outcome Measure Information:
    Title
    The number of patients with clinically relevant changes in clinically laboratory tests
    Time Frame
    Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up)
    Title
    Number of patients with neutropenia
    Time Frame
    Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up)
    Title
    Plasma concentrations of trabectedin (Yondelis)
    Time Frame
    During the first 3 weeks of treatment
    Title
    Plasma concentrations of Doxorubicin
    Time Frame
    During the first 3 weeks of treatment
    Title
    Plasma concentrations of Doxorubicinol
    Time Frame
    During the first 3 weeks of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have a diagnosis of soft tissue sarcoma, recurrent or persistent Signed informed consent obtained for all patients before performing any study-related procedures Exclusion Criteria: Patients treated with more than 1 prior chemotherapy regimen (including adjuvant (or other additional) therapy) Previous exposure to anthracyclines (a class of drugs used in cancer chemotherapy, example is Doxorubicin) or trabectedin Less than 4 weeks since radiation therapy Known metastases (spread) of cancer to the central nervous system Other ongoing serious illness present at the time of enrollment as determined by the Investigator
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research and Development, LLC Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research and Development, LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma

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