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Alkylating agents

Metronomic Chemotherapy for Leiomyosarcoma (TAGGED Trial)

Phase 2
Recruiting
Led By Sant P Chawla, MD
Research Sponsored by Sarcoma Oncology Research Center, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acceptable renal function: Creatinine < 1.5 times ULN and creatinine clearance > 60 ml/min using the Crockroft-Gault formula
Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic leiomyosarcoma
Must not have
Subject has known sensitivity to trabectedin, gemcitabine or dacarbazine
Sexually active subjects and their partners unwilling to use male or female latex condom
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 10 Other Conditions

Summary

This trial is testing a new combination of drugs to treat cancer. The drugs are given at lower doses than usual, and more often.

Who is the study for?
Adults with advanced leiomyosarcoma, previously treated and measurable by certain criteria, can join this trial. They must have a life expectancy of at least 3 months, be able to perform daily activities (ECOG ≤ 2), and have proper liver, kidney, and blood function. Participants must agree to use effective contraception during the study.
What is being tested?
The trial is testing metronomic doses of trabectedin combined with gemcitabine and dacarbazine in patients with leiomyosarcoma. It's an open-label phase 2 study where all participants receive the drugs intravenously to evaluate their effectiveness.
What are the potential side effects?
Potential side effects include nausea, fatigue, decreased appetite, hair loss (alopecia), constipation or diarrhea. There may also be risks of lowered blood cell counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is within the required range.
Select...
My cancer is a type called leiomyosarcoma and cannot be removed by surgery.
Select...
I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am allergic to trabectedin, gemcitabine, or dacarbazine.
Select...
I or my partner refuse to use condoms during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression free survival
Secondary study objectives
Adverse Event
Overall Response

Side effects data

From 2010 Phase 3 trial • 672 Patients • NCT00113607
77%
Neutropenia
75%
Nausea
56%
Alanine Aminotransferase Increased
56%
Vomiting
49%
Leukopenia
48%
Anaemia
46%
Fatigue
42%
Aspartate Aminotransferase Increased
35%
Thrombocytopenia
33%
Constipation
33%
Anorexia
26%
Palmar-Plantar Erythrodysaesthesia Syndrome
25%
Diarrhoea
23%
Blood Alkaline Phosphatase Increased
21%
Abdominal Pain
20%
Stomatitis
19%
Pyrexia
17%
Headache
17%
Asthenia
16%
Dyspnoea
15%
Hyperbilirubinaemia
13%
Dyspepsia
13%
Alopecia
13%
Mucosal Inflammation
12%
Cough
11%
Hypokalaemia
11%
Rash
10%
Dizziness
10%
Insomnia
9%
Oedema Peripheral
9%
Back Pain
7%
Anxiety
7%
Blood Creatine Phosphokinase Increased
7%
Hypoalbuminaemia
6%
Pain in Extremity
6%
Dysgeusia
6%
Skin Hyperpigmentation
6%
Abdominal Pain Upper
6%
Arthralgia
6%
Blood Creatinine Increased
6%
Hyponatraemia
5%
Abdominal Distension
5%
Myalgia
5%
Pain
5%
Urinary Tract Infection
5%
Febrile Neutropenia
5%
Dry Skin
5%
Pharyngolaryngeal Pain
5%
Erythema
4%
Ascites
4%
Pulmonary Embolism
3%
Mouth Ulceration
3%
Pruritus
2%
Intestinal Obstruction
2%
Pancytopenia
2%
Small Intestinal Obstruction
2%
Dehydration
1%
Subclavian Vein Thrombosis
1%
Syncope
1%
Colonic Obstruction
1%
Bone Marrow Failure
1%
Cardiac Failure Congestive
1%
Catheter Related Complication
1%
General Physical Health Deterioration
1%
Non-Cardiac Chest Pain
1%
Catheter Related Infection
1%
Catheter Site Infection
1%
Hypersensitivity
1%
Bacteraemia
1%
Neutropenic Sepsis
1%
Neutropenic Infection
1%
Pneumonia
1%
Thrombosis
1%
Renal Failure Acute
1%
Pleural Effusion
1%
Axillary Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trabectedin/DOXIL
DOXIL

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
Trabectedin 24 h CIV 0.5 mg/m2 D1 and D8 Gemcitabine i.v. 250 mg/m2 D1 and D8 Dacarbazine i.v. 250 mg/m2 D1 and D8
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trabectedin
FDA approved

Find a Location

Who is running the clinical trial?

Sarcoma Oncology Research Center, LLCLead Sponsor
8 Previous Clinical Trials
486 Total Patients Enrolled
Sant P Chawla, MDPrincipal InvestigatorSarcoma Oncology Research Center, LLC
6 Previous Clinical Trials
404 Total Patients Enrolled

Media Library

Trabectedin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04535271 — Phase 2
Leiomyosarcoma Research Study Groups: Single arm
Leiomyosarcoma Clinical Trial 2023: Trabectedin Highlights & Side Effects. Trial Name: NCT04535271 — Phase 2
Trabectedin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04535271 — Phase 2
~19 spots leftby Dec 2025
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