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

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	Complete list of historical versions of study NCT00102609 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	Phase 1
Study Design ICMJE	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	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	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	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	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	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