A Phase 1 interventional study of Doxorubicin and Trabectedin in Soft Tissue Sarcoma, Sarcoma and Neoplasms, Connective and Soft Tissue, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-10.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 41 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Drug: Doxorubicin · Drug: Trabectedin · Drug: Dexamethasone
Doxorubicin 50 to 75 mg/m2 administered intravenously on Day 1
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 within 1 hour before the start of doxorubicin
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)
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
No study locations are listed for this record.
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.