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

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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

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

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

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

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

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

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