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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
TAGGED Trial 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.Check my eligibility
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.See study design
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.
TAGGED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
TAGGED Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival
Secondary outcome measures
Adverse Event
Overall Response
Side effects data
From 2010 Phase 3 trial • 672 Patients • NCT0011360777%
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
TAGGED 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
7 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My kidney function is within the required range.I am a woman able to have children and agree to use birth control during and for 3 months after treatment.My liver functions within normal limits, or close to it, even if I have liver metastases.I am not currently in another drug study and it's been over 14 days since my last one.My cancer is a type called leiomyosarcoma and cannot be removed by surgery.I am not pregnant and agree to use effective birth control during and after the study.I am allergic to trabectedin, gemcitabine, or dacarbazine.My blood clotting tests are normal or managed if I'm on blood thinners.My cancer's size can be measured by standard health scans.I or my partner refuse to use condoms during the trial.You are expected to live for at least 3 more months.I am willing and able to follow all study rules and attend all appointments.I can take care of myself but might not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are currently taking part in this research?
"Affirmative. According to clinicaltrials.gov, this medical investigation was first advertised on September 9th 2021 and is still actively recruiting patients. 80 people are needed from one trial centre for the completion of this research project."
Answered by AI
Are researchers presently enrolling participants in this experiment?
"Clinicaltrials.gov reports that this research is actively recruiting patients. The original posting for the study was September 9th 2021 and it has since been amended on October 13th 2022."
Answered by AI
Are there any known risks associated with Trabectedin therapy?
"Due to the Phase 2 nature of this clinical trial, our team at Power assigned it a score of 2 for safety as there is evidence supporting its security but no proof regarding its efficacy."
Answered by AI
Has Trabectedin been evaluated in prior clinical investigations?
"At present, Trabectedin is being studied in 490 active clinical trials with 144 of them being conducted during the final phase. Out of 25653 different sites that are running these studies, several are located in Adelaide, South Australia."
Answered by AI
What maladies has Trabectedin been demonstrated to combat?
"Trabectedin is the go-to treatment for small cell lung cancer, and has also been known to be effective against lymphoma, Hodgkin's disease, head and neck carcinomas, as well as cervical cancers."
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Sant P Chawla
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