A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma
Overview[ - collapse ][ - ]
| 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 | Soft Tissue Sarcoma Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
| Intervention | Drug: Doxorubicin Drug: Trabectedin Drug: Dexamethasone |
| Phase | Phase 1 |
| Sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| 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 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 31, 2005 |
|---|---|
| Last Updated Date | January 9, 2013 |
| Start Date | April 2005 |
| Estimated Primary Completion Date | October 2007 |
| Current 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] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma |
|---|---|
| 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 |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | 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 |
| Study Arm (s) | 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. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 41 |
| Estimated Completion Date | October 2007 |
| Estimated Primary Completion Date | Not Provided |
| 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00102609 |
|---|---|
| Other Study ID Numbers | CR003250 |
| Has Data Monitoring Committee | No |
| Information Provided By | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Study Sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Collaborators | PharmaMar PharmaMar S.A.U. |
| Investigators | Study Director: Johnson & Johnson Pharmaceutical Research and Development, LLC Clinical Trial Johnson & Johnson Pharmaceutical Research and Development, LLC |
| Verification Date | January 2013 |