NCT00070109|CompletedPhase 2ResultsDMC

Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors

A Phase II Study Of Trabectedin (ET-743, Yondelis®) in Children With Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomyosarcomatous Soft Tissue Sarcomas

Children's Oncology Group ClinicalTrials.gov

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5 other identifiers

ADVL0221NCI-2009-00357CDR0000329999COG-ADVL0221U10CA098543

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredOct 2003

StartedJan 2008

CompletionDec 2013

Brief Summary

This phase II trial is studying how well trabectedin works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they stop growing or die.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jan 2008

Longer than P75 for phase_2

Geographic Reach

2 countries

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.9 years study duration

First Submitted

Initial submission to the registry

October 3, 2003

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed

4.2 years until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed

3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed

2 months until next milestone

Results Posted

Study results publicly available

January 27, 2014

Completed

Last Updated

September 14, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

October 3, 2003

Results QC Date

December 9, 2013

Last Update Submit

August 13, 2018

Conditions

Previously Treated Childhood Rhabdomyosarcoma Recurrent Childhood Rhabdomyosarcoma Recurrent Childhood Soft Tissue Sarcoma Recurrent Ewing Sarcoma Peripheral Primitive Neuroectodermal Tumor

Outcome Measures

Primary Outcomes (7)

Response (Complete Response [CR] and Partial Response [PR])
Any patient who is enrolled and receives at least one dose of trabectedin will be considered evaluable for response if the individual receives at least one dose of trabectedin and: (1) is removed from protocol therapy because of progressive disease where progressive disease is documented either by imaging studies or clinical progression; or (2) has at least one radiographic evaluation of disease status after the start of protocol therapy and is not electively removed from protocol therapy with stable disease or is not lost to follow-up with stable disease. Patients who achieve a complete response (CR) - disappearance of all target lesions or partial response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions according to the RECIST criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.
Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first.
Number of Patients With Dose-Limiting Toxicity (DLT)
Any Grade 3 or Grade 4 non-hematologic toxicity attributable to the Investigational drug with the specific exclusion of: Grade 3 nausea and vomiting; Grade 3 transaminase (AST/ALT) elevation that return to less than or equal to Grade 1 or baseline prior to the time for the next treatment cycle; Grade 3 fever or infection; Alopecia; Grade 4 neutropenia of \> 7 days duration or Grade 4 thrombocytopenia of \> 7 days duration, which requires transfusion therapy on greater than 2 occasions in 7 days, or which causes a delay of more than 14 days beyond the planned interval between treatment cycles.
1 Cycle
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Maximum Plasma Concentration (Cmax) of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Cmax was derived for each patient.
From baseline up to168 hours after trabectedin infusion in course 1
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Apparent Volume at Steady State (Vss) of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Vss was derived for each patient.
From baseline up to168 hours after trabectedin infusion in course 1
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Half-life of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Half-life was derived for each patient.
From baseline up to168 hours after trabectedin infusion in course 1
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Area Under the Curve (AUC) of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated AUC was derived for each patient.
From baseline up to168 hours after trabectedin infusion in course 1
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Clearance of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Clearance was derived for each patient.
From baseline up to168 hours after trabectedin infusion in course 1

Study Arms (5)

Trabectedin 1.3 mg/m2 to assess feasibility in all patients

EXPERIMENTAL

Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. A cohort of 6 patients will be enrolled at the 1.3 mg/m2 dose level.