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

This study has been completed.
Sponsor:
Collaborators:
PharmaMar
PharmaMar S.A.U.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00102609
First received: January 31, 2005
Last updated: January 9, 2013
Last verified: January 2013
History of Changes

January 31, 2005
January 9, 2013
April 2005
Not Provided
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) ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00102609 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: Yes ]
  • Number of patients with neutropenia [ Time Frame: Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up) ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of trabectedin (Yondelis) [ Time Frame: During the first 3 weeks of treatment ] [ Designated as safety issue: No ]
  • Plasma concentrations of Doxorubicin [ Time Frame: During the first 3 weeks of treatment ] [ Designated as safety issue: No ]
  • Plasma concentrations of Doxorubicinol [ Time Frame: During the first 3 weeks of treatment ] [ Designated as safety issue: No ]
Not Provided
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A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma
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
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.
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.
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Soft Tissue Sarcoma
  • Sarcoma
  • Neoplasms, Connective and Soft Tissue
  • Neoplasms by Histologic Type
  • Neoplasms
  • 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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
October 2007
Not Provided

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
France,   United States
 
NCT00102609
CR003250, ET743SAR1001
No
Not Provided
Not Provided
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  • PharmaMar
  • PharmaMar S.A.U.
Study Director: Johnson & Johnson Pharmaceutical Research and Development, LLC Clinical Trial Johnson & Johnson Pharmaceutical Research and Development, LLC
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
January 2013

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