At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed soft-tissue sarcoma with metastatic or unresectable locally advanced disease
- ✓ECOG performance status ≤2
- ✓Age ≥18 years with life expectancy >3 months
- ✓Measurable disease by RECIST v1.1 outside previously irradiated fields
- ✕Prior treatment with trabectedin
- ✕Active bacterial or fungal infection >grade 2, or HIV/hepatitis B/C infection
- ✕History of chronic alcohol use and/or cirrhosis
- ✕Unstable cardiac conditions including CHF, angina, MI within 1 year, uncontrolled hypertension (≥150/100 mmHg), or clinically significant arrhythmias
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide (CP) in Patients With Advanced Pretreated Soft-tissue Sarcomas. A Phase I/II Study From the French Sarcoma Group.
In Brief
A Phase 2 clinical trial evaluating Phase 1: Trabectedin, Phase 2: Trabectedin, and 2 other interventions for Soft-tissue Sarcomas. Completed, enrolled 50 participants across 1 site.
Detailed Summary
Assessment of the efficacy and safety of trabectedin and metronomic cyclophosphamide (CP) in patients with advanced pretreated soft-tissue sarcomas, once the Maximum Tolerated Dose (MTD) have been determined (phase I trial).
Study Details
Timeline
Interventions
Phase I trial based on a dose escalating study design (3+3 traditional design) assessing four dose levels of Trabectedin in combination with metronomic cyclophosphamide (CP). A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)
Patients will be included in a single-arm phase II trial. Administrated dose will be the RP2D defined in the dose escalation part of the trial. The design will follow a two-stage Simon's optimal design. All patients will be treated at the RP2D of trabectedin defined in the preliminary phase I trial with the same schedule as in the phase I trial.
A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
All patients will be treated with metronomic cyclophosphamide with the same schedule as in the phase I trial.