A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer

Leiomyosarcoma Clinical Trial

Official title:

A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00060944
• Other study ID #: CR004336
• Secondary ID: ET743-STS-201
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2003
• Last updated: August 28, 2014
• Start date: May 2003
• Est. completion date: May 2008

Study information

• Verified date: August 2014
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.

Description:

This is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients with 2 types of cancer (Liposarcoma or Leiomyosarcoma) who have received treatment with other anti-cancer therapy (Anthracycline and/or Ifosfamide). Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer. Yondelis will be administered intravenously (i.v.) via a central catheter (tube) into a central vein once a week (0.58 mg/m2 as a 3-hour infusion on Days 1, 8, and 15 of each 28-day treatment cycle) or once every 3 weeks (1.5 mg/m2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle) until disease progression. Patients in each arm will be pretreated with 20 mg of dexamethasone i.v. 30 minutes prior to each infusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)

• Have a pathology specimen available for centralized review

• Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study, and have at least one measurable tumor lesion

• Have adequate bone marrow, liver and kidney function

• Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

• Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)

• Cancer that has metastasized (spread) to the central nervous system

• Active viral hepatitis or chronic liver disease

• Unstable cardiac (heart) condition including congestive heart failure or angina pectoris (heart pain), myocardial infarction (heart attack) within 1 year before enrollment

• History of another neoplastic (malignant or nonmalignant tumor) disease (except basal cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5 years or more before enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyosarcoma
• Liposarcoma

Intervention

Drug:
• Yondelis
1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle.
• Yondelis
0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
• Dexamethasone
Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
• Dexamethasone
Pretreatment with 20 mg of dexamethasone i.v. on Day 1 of each 21- day treatment cycle, 30 minutes prior to each Yondelis infusion.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	PharmaMar

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression- Independent Review	Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.	From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years	Yes
Secondary	Percentage of Participants Objective Response - Independent Review	Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.	From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years	No
Secondary	Duration of Response - Independent Review	Duration of response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response.	From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years	No
Secondary	Progression-Free Survival - Independent Review	The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.	From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years	No
Secondary	Overall Survival	The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.	From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years	No

External Links

•   Demetri GD et al. J Clin Oncol. 2009;27(25):4188-96.