Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00102609
Recruitment Status : Completed
First Posted : February 1, 2005
Last Update Posted : January 10, 2013
Sponsor:
Collaborators:
PharmaMar
PharmaMar S.A.U.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE January 31, 2005
First Posted Date  ICMJE February 1, 2005
Last Update Posted Date January 10, 2013
Study Start Date  ICMJE April 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2011)
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) ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2011)
  • 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) ]
  • Number of patients with neutropenia [ Time Frame: Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up) ]
  • Plasma concentrations of trabectedin (Yondelis) [ Time Frame: During the first 3 weeks of treatment ]
  • Plasma concentrations of Doxorubicin [ Time Frame: During the first 3 weeks of treatment ]
  • Plasma concentrations of Doxorubicinol [ Time Frame: During the first 3 weeks of treatment ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Soft Tissue Sarcoma
  • Sarcoma
  • Neoplasms, Connective and Soft Tissue
  • Neoplasms by Histologic Type
  • Neoplasms
Intervention  ICMJE
  • Drug: Doxorubicin
    Doxorubicin 50 to 75 mg/m2 administered intravenously on Day 1
  • Drug: Trabectedin
    Trabectedin 0.9 to 1.3 mg/m2 administered intravenously on Day 1 every 3 weeks for up to 6 cycles
  • Drug: Dexamethasone
    Dexamethasone 20 mg administered intravenously within 1 hour before the start of doxorubicin
Study Arms  ICMJE Experimental: Trabectedin and doxorubicin
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.
Interventions:
  • Drug: Doxorubicin
  • Drug: Trabectedin
  • Drug: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2011)
41
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries France,   United States
 
Administrative Information
NCT Number  ICMJE NCT00102609
Other Study ID Numbers  ICMJE CR003250
ET743SAR1001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE
  • PharmaMar
  • PharmaMar S.A.U.
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research and Development, LLC Clinical Trial Johnson & Johnson Pharmaceutical Research and Development, LLC
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date January 2013

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