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

This study has been completed.
Sponsor:
Collaborators:
PharmaMar
PharmaMar S.A.U.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00102609
First received: January 31, 2005
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Soft Tissue Sarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Drug: Doxorubicin
Drug: Trabectedin
Drug: Dexamethasone
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • Number of patients with neutropenia [ Time Frame: Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up) ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of trabectedin (Yondelis) [ Time Frame: During the first 3 weeks of treatment ] [ Designated as safety issue: No ]
  • Plasma concentrations of Doxorubicin [ Time Frame: During the first 3 weeks of treatment ] [ Designated as safety issue: No ]
  • Plasma concentrations of Doxorubicinol [ Time Frame: During the first 3 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: April 2005
Study Completion Date: October 2007
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102609

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

Additional Information:
No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00102609     History of Changes
Other Study ID Numbers: CR003250, ET743SAR1001
Study First Received: January 31, 2005
Last Updated: January 9, 2013
Health Authority: United States: Food and Drug Administration

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:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Sarcoma
Trabectedin
Antineoplastic Agents
Dexamethasone
Doxorubicin
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on July 23, 2014