Trial Outcomes & Findings for Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma (NCT NCT00579501)
NCT ID: NCT00579501
Last Updated: 2014-05-07
Results Overview
Complete pathological response is complete disappearance of the tumor tissue up to the molecular level.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.
Results posted on
2014-05-07
Participant Flow
Participant milestones
| Measure |
Trabectedin
Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
Trabectedin
Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
End of neoadjuvant therapy
|
25
|
|
Overall Study
toxicity
|
1
|
|
Overall Study
Secondary lesion
|
1
|
|
Overall Study
Radiation therapy before surgery
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma
Baseline characteristics by cohort
| Measure |
Trabectedin
n=29 Participants
Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
|
|---|---|
|
Age, Customized
18-49 years
|
15 participants
n=39 Participants
|
|
Age, Customized
50-69 years
|
10 participants
n=39 Participants
|
|
Age, Customized
greater than or equal to 70 years
|
4 participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.Population: Participants who received at least one cycle of trabectedin and have adequate pre and post trabectedin pathologic specimens available. Six participants were non evaluable for pCR assessment.
Complete pathological response is complete disappearance of the tumor tissue up to the molecular level.
Outcome measures
| Measure |
Trabectedin
n=23 Participants
Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
|
|---|---|
|
Percentage of Participants With Pathological Complete Response (pCR)
|
13 percentage of participants
|
SECONDARY outcome
Timeframe: Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.Population: Participants who received at least one cycle of trabectedin and have at least one post baseline disease assessment.
The objective tumor response is defined as the percentage of participants achieving partial response (PR) on tumor response assessed by RECIST. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
Trabectedin
n=29 Participants
Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
|
|---|---|
|
Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST)
|
24.1 percentage of participants
|
Adverse Events
Trabectedin
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trabectedin
n=29 participants at risk
Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
|
|---|---|
|
Gastrointestinal disorders
Colitis ischaemic
|
3.4%
1/29
|
|
Gastrointestinal disorders
Constipation
|
3.4%
1/29
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29
|
|
Gastrointestinal disorders
Stomatitis
|
3.4%
1/29
|
|
General disorders
Asthenia
|
3.4%
1/29
|
|
Hepatobiliary disorders
Hepatic failure
|
3.4%
1/29
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
1/29
|
|
Investigations
Aspartate aminotransferase increased
|
3.4%
1/29
|
|
Investigations
Liver function test abnormal
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
3.4%
1/29
|
|
Renal and urinary disorders
Renal failure
|
3.4%
1/29
|
Other adverse events
| Measure |
Trabectedin
n=29 participants at risk
Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.9%
2/29
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Neutropenia
|
48.3%
14/29
|
|
Cardiac disorders
Bradycardia
|
3.4%
1/29
|
|
Cardiac disorders
Palpitations
|
3.4%
1/29
|
|
Cardiac disorders
Tachycardia
|
6.9%
2/29
|
|
Cardiac disorders
Ventricular extrasystoles
|
3.4%
1/29
|
|
Gastrointestinal disorders
Abdominal pain
|
13.8%
4/29
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.4%
1/29
|
|
Gastrointestinal disorders
Constipation
|
24.1%
7/29
|
|
Gastrointestinal disorders
Diarrhoea
|
10.3%
3/29
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
1/29
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.4%
1/29
|
|
Gastrointestinal disorders
Nausea
|
75.9%
22/29
|
|
Gastrointestinal disorders
Reflux gastritis
|
3.4%
1/29
|
|
Gastrointestinal disorders
Stomach discomfort
|
3.4%
1/29
|
|
Gastrointestinal disorders
Vomiting
|
27.6%
8/29
|
|
General disorders
Chest pain
|
3.4%
1/29
|
|
General disorders
Chills
|
3.4%
1/29
|
|
General disorders
Fatigue
|
65.5%
19/29
|
|
General disorders
Infusion site pain
|
6.9%
2/29
|
|
General disorders
Mucosal inflammation
|
3.4%
1/29
|
|
General disorders
Oedema
|
10.3%
3/29
|
|
General disorders
Oedema peripheral
|
10.3%
3/29
|
|
General disorders
Pyrexia
|
27.6%
8/29
|
|
Hepatobiliary disorders
Hepatotoxicity
|
3.4%
1/29
|
|
Immune system disorders
Hypersensitivity
|
3.4%
1/29
|
|
Infections and infestations
Bronchitis
|
3.4%
1/29
|
|
Infections and infestations
Gastroenteritis
|
3.4%
1/29
|
|
Infections and infestations
Herpes zoster
|
3.4%
1/29
|
|
Infections and infestations
Influenza
|
3.4%
1/29
|
|
Infections and infestations
Injection site infection
|
3.4%
1/29
|
|
Infections and infestations
Tooth infection
|
3.4%
1/29
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
3.4%
1/29
|
|
Investigations
Alanine aminotransferase increased
|
20.7%
6/29
|
|
Investigations
Blood bilirubin increased
|
6.9%
2/29
|
|
Investigations
Blood creatine phosphokinase increased
|
3.4%
1/29
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.4%
1/29
|
|
Investigations
Weight decreased
|
6.9%
2/29
|
|
Investigations
Weight increased
|
6.9%
2/29
|
|
Metabolism and nutrition disorders
Anorexia
|
10.3%
3/29
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.4%
1/29
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
3/29
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
1/29
|
|
Nervous system disorders
Paraesthesia
|
3.4%
1/29
|
|
Psychiatric disorders
Anxiety
|
6.9%
2/29
|
|
Psychiatric disorders
Depression
|
3.4%
1/29
|
|
Psychiatric disorders
Insomnia
|
10.3%
3/29
|
|
Renal and urinary disorders
Pollakiuria
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
10.3%
3/29
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.4%
1/29
|
|
Vascular disorders
Hypertension
|
3.4%
1/29
|
|
Vascular disorders
Phlebitis
|
6.9%
2/29
|
|
Vascular disorders
Thrombophlebitis superficial
|
3.4%
1/29
|
|
Nervous system disorders
Headache
|
17.2%
5/29
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
20.7%
6/29
|
Additional Information
Medical Specialist, Clinical Oncology
PharmaMar SA, Av de los Reyes 1 Mine Industrial Estate, 28770 Colmenar Viejo, Madrid, Spain
Phone: +34 91 646-6087
Results disclosure agreements
- Principal investigator is a sponsor employee Before submitting the paper or abstract or disclose information to public concerning trabectedin (YONDELIS®), PharmaMar must be provided of 15 days in case of abstract and 30 days in case of full paper, to review and approve the publication to assure that confidential and proprietary data are protected. Primary authorship for publication is hold by the coordinating investigator of this project. Following authors will be named according to the number of patients treated under this protocol.
- Publication restrictions are in place
Restriction type: OTHER