ClinicalTrials.gov processed this data on March 29, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00102609CR003250ET743SAR1001NCT00102609A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue SarcomaA 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 SarcomaJohnson & Johnson Pharmaceutical Research & Development, L.L.C.IndustryPharmaMarIndustryPharmaMar S.A.U.OtherNo
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.
CompletedApril 2005October 2007Phase 1InterventionalNoN/ASingle Group AssignmentTreatmentNone (Open Label)Number of patients with adverse events as a measure of safetyUp to approximately 19 weeks (six 3-week treatment cycles+30 day safety follow up)The number of patients with clinically relevant changes in clinically laboratory testsUp to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up)Number of patients with neutropeniaUp to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up)Plasma concentrations of trabectedin (Yondelis)During the first 3 weeks of treatmentPlasma concentrations of DoxorubicinDuring the first 3 weeks of treatmentPlasma concentrations of DoxorubicinolDuring the first 3 weeks of treatment141Soft Tissue SarcomaSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsTrabectedin and doxorubicinExperimentalDoxorubicin (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.DrugDoxorubicinDoxorubicin 50 to 75 mg/m2 administered intravenously on Day 1Trabectedin and doxorubicinDrugTrabectedinTrabectedin 0.9 to 1.3 mg/m2 administered intravenously on Day 1 every 3 weeks for up to 6 cyclesTrabectedin and doxorubicinDrugDexamethasoneDexamethasone 20 mg administered intravenously within 1 hour before the start of doxorubicinTrabectedin and doxorubicin
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
All18 YearsN/ANoJohnson & Johnson Pharmaceutical Research and Development, LLC Clinical TrialStudy DirectorJohnson & Johnson Pharmaceutical Research and Development, LLCFranceUnited StatesJanuary 2013January 31, 2005January 31, 2005February 1, 2005January 9, 2013January 9, 2013January 10, 2013SponsorDoxorubicinAdriamycinTrabectedinYondelisEcteinascidin 743Filgrastim, AntineoplasticAntineoplastic AgentsPharmacologic ActionsAlkylating AgentsNeoplasmsSarcomaNeoplasms by Histologic TypeNeoplasms, Connective and Soft TissueDexamethasoneDoxorubicinTrabectedin