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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Soft Tissue Sarcoma, Sarcoma, Neoplasms, Connective and Soft Tissue, Neoplasms by Histologic Type, Neoplasms

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of patients with adverse events as a measure of safety

Outcome Time Frame:

Up to approximately 19 weeks (six 3-week treatment cycles+30 day safety follow up)

Safety Issue:

Yes

Principal Investigator

Johnson & Johnson Pharmaceutical Research and Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Pharmaceutical Research and Development, LLC

Authority:

United States: Food and Drug Administration

Study ID:

CR003250

NCT ID:

NCT00102609

Start Date:

April 2005

Completion Date:

October 2007

Related Keywords:

  • Soft Tissue Sarcoma
  • Sarcoma
  • Neoplasms, Connective and Soft Tissue
  • Neoplasms by Histologic Type
  • Neoplasms
  • Doxorubicin
  • Adriamycin
  • Trabectedin
  • Yondelis
  • Ecteinascidin 743
  • Filgrastim, Antineoplastic
  • Antineoplastic Agents
  • Pharmacologic Actions
  • Alkylating Agents
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms, Connective and Soft Tissue
  • Sarcoma

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