Neoplasms, Neoplasms by Histologic Type, Neoplasms, Connective and Soft Tissue, Sarcoma, Soft Tissue Sarcoma
Conditions
Keywords
Doxorubicin, Adriamycin, Trabectedin, Yondelis, Ecteinascidin 743, Filgrastim, Antineoplastic, Antineoplastic Agents, Pharmacologic Actions, Alkylating Agents
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.
Interventions
DRUGDoxorubicin
Doxorubicin 50 to 75 mg/m2 administered intravenously on Day 1
DRUGTrabectedin
Trabectedin 0.9 to 1.3 mg/m2 administered intravenously on Day 1 every 3 weeks for up to 6 cycles
DRUGDexamethasone
Dexamethasone 20 mg administered intravenously within 1 hour before the start of doxorubicin
Sponsors
PharmaMar
PharmaMar S.A.U.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events as a measure of safety | Up to approximately 19 weeks (six 3-week treatment cycles+30 day safety follow up) |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of Doxorubicin | During the first 3 weeks of treatment |
| The number of patients with clinically relevant changes in clinically laboratory tests | Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up) |
| Number of patients with neutropenia | Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up) |
| Plasma concentrations of trabectedin (Yondelis) | During the first 3 weeks of treatment |
| Plasma concentrations of Doxorubicinol | During the first 3 weeks of treatment |
Outcome results
None listed