A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma

Neoplasms Clinical Trial

Official title:

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

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
• 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

• Neoplasms
• Neoplasms by Histologic Type
• Neoplasms, Connective and Soft Tissue
• Sarcoma
• Soft Tissue Sarcoma

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

External Links

•   Blay J, von Mehren M, Samuels BL, et al. Phase I combination study of trabectedin and doxorubicin in patients with soft-tissue sarcoma. Clin Cancer Res. 2008:14; 6656.