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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00102609
Recruitment Status : Completed
First Posted : February 1, 2005
Last Update Posted : January 10, 2013
Sponsor:
Collaborators:
PharmaMar
PharmaMar S.A.U.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Drug: Doxorubicin Drug: Trabectedin Drug: Dexamethasone Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2005
Actual Study Completion Date : October 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Doxorubicin
Doxorubicin 50 to 75 mg/m2 administered intravenously on Day 1

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with adverse events as a measure of safety [ Time Frame: Up to approximately 19 weeks (six 3-week treatment cycles+30 day safety follow up) ]

Secondary Outcome Measures :
  1. The number of patients with clinically relevant changes in clinically laboratory tests [ Time Frame: Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up) ]
  2. Number of patients with neutropenia [ Time Frame: Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up) ]
  3. Plasma concentrations of trabectedin (Yondelis) [ Time Frame: During the first 3 weeks of treatment ]
  4. Plasma concentrations of Doxorubicin [ Time Frame: During the first 3 weeks of treatment ]
  5. Plasma concentrations of Doxorubicinol [ Time Frame: During the first 3 weeks of treatment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102609


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar
PharmaMar S.A.U.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research and Development, LLC Clinical Trial Johnson & Johnson Pharmaceutical Research and Development, LLC
More Information
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Additional Information:

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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00102609    
Other Study ID Numbers: CR003250
ET743SAR1001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
First Posted: February 1, 2005    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Doxorubicin
Adriamycin
Trabectedin
Yondelis
Ecteinascidin 743
 Filgrastim, Antineoplastic
Antineoplastic Agents
Pharmacologic Actions
Alkylating Agents
Additional relevant MeSH terms:
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Neoplasms
Sarcoma
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Dexamethasone
Doxorubicin
Trabectedin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents