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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00102609
Other study ID # CR003250
Secondary ID ET743SAR1001
Status Completed
Phase Phase 1
First received January 31, 2005
Last updated January 9, 2013
Start date April 2005
Est. completion date October 2007

Study information

Verified date January 2013
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Doxorubicin
Doxorubicin 50 to 75 mg/m2 administered intravenously on Day 1
Trabectedin
Trabectedin 0.9 to 1.3 mg/m2 administered intravenously on Day 1 every 3 weeks for up to 6 cycles
Dexamethasone
Dexamethasone 20 mg administered intravenously within 1 hour before the start of doxorubicin

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar, PharmaMar S.A.U.

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Yes
Secondary 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) Yes
Secondary Number of patients with neutropenia Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up) Yes
Secondary Plasma concentrations of trabectedin (Yondelis) During the first 3 weeks of treatment No
Secondary Plasma concentrations of Doxorubicin During the first 3 weeks of treatment No
Secondary Plasma concentrations of Doxorubicinol During the first 3 weeks of treatment No
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