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

NCT ID: NCT00102609

Last Updated: 2013-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2007-10-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trabectedin and doxorubicin

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.

Group Type: EXPERIMENTAL

Doxorubicin

Intervention Type: DRUG

Doxorubicin 50 to 75 mg/m2 administered intravenously on Day 1

Trabectedin

Intervention Type: DRUG

Trabectedin 0.9 to 1.3 mg/m2 administered intravenously on Day 1 every 3 weeks for up to 6 cycles

Dexamethasone

Intervention Type: DRUG

Dexamethasone 20 mg administered intravenously within 1 hour before the start of doxorubicin

Interventions

Doxorubicin

Doxorubicin 50 to 75 mg/m2 administered intravenously on Day 1

Intervention Type: DRUG

Trabectedin

Trabectedin 0.9 to 1.3 mg/m2 administered intravenously on Day 1 every 3 weeks for up to 6 cycles

Intervention Type: DRUG

Dexamethasone

Dexamethasone 20 mg administered intravenously within 1 hour before the start of doxorubicin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaMar

INDUSTRY

Sponsor Role: collaborator

PharmaMar S.A.U.

UNKNOWN

Sponsor Role: collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research and Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research and Development, LLC

Other Identifiers

ET743SAR1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR003250

Identifier Type: -

Identifier Source: org_study_id