Clinical trial NCT00102609: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Soft Tissue Sarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Keywords: Doxorubicin
Adriamycin
Trabectedin
Yondelis
Ecteinascidin 743
Filgrastim, Antineoplastic
Antineoplastic Agents
Pharmacologic Actions
Alkylating Agents
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: PharmaMar
name: PharmaMar S.A.U.
First posted: 2005-02-01
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of patients with adverse events as a measure of safety
timeFrame: Up to approximately 19 weeks (six 3-week treatment cycles+30 day safety follow up)
Secondary outcomes:
measure: The number of patients with clinically relevant changes in clinically laboratory tests
timeFrame: Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up)
measure: Number of patients with neutropenia
timeFrame: Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up)
measure: Plasma concentrations of trabectedin (Yondelis)
timeFrame: During the first 3 weeks of treatment
measure: Plasma concentrations of Doxorubicin
timeFrame: During the first 3 weeks of treatment
measure: Plasma concentrations of Doxorubicinol
timeFrame: During the first 3 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research and Development, LLC
name: Johnson & Johnson Pharmaceutical Research and Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: