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Trial record 74 of 430 for:    ifosfamide

An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)

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ClinicalTrials.gov Identifier: NCT00796120
Recruitment Status : Completed
First Posted : November 24, 2008
Results First Posted : September 16, 2014
Last Update Posted : December 10, 2015
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sarcoma
Interventions Drug: Trabectedin
Drug: Doxorubicin
Drug: Ifosfamide
Enrollment 121
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trabectedin Doxorubicin Plus Ifosfamide
Hide Arm/Group Description Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
Period Title: Overall Study
Started 61 60
Treated 61 57
Completed 0 0
Not Completed 61 60
Reason Not Completed
Death             3             0
Adverse Event             11             6
Progressive disease             22             13
Participant refusal             3             4
Other             6             17
Physician Decision             16             17
Randomized but not treated             0             3
Arm/Group Title Trabectedin Doxorubicin Plus Ifosfamide Total
Hide Arm/Group Description Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression. Total of all reporting groups
Overall Number of Baseline Participants 61 60 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
>=18 to <=49 years 33 30 63
>=50 to <=65 years 19 21 40
>=65 years 9 9 18
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
Female
25
  41.0%
22
  36.7%
47
  38.8%
Male
36
  59.0%
38
  63.3%
74
  61.2%
1.Primary Outcome
Title Progression - Free Survival (PFS)
Hide Description The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
Time Frame Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of translocation-related sarcomas (TRS)
Arm/Group Title Trabectedin Doxorubicin Plus Ifosfamide
Hide Arm/Group Description:
Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
Overall Number of Participants Analyzed 51 37
Median (95% Confidence Interval)
Unit of Measure: months
19.6
(5.7 to 32.3)
8.3
(7.1 to 25.0)
2.Secondary Outcome
Title 6-month Progression - Free Survival
Hide Description Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.
Arm/Group Title Trabectedin Doxorubicin Plus Ifosfamide
Hide Arm/Group Description:
Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
Overall Number of Participants Analyzed 51 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
66.7
(50.6 to 82.8)
78.3
(64.0 to 92.5)
3.Secondary Outcome
Title Percentage of Participants With Objective Response
Hide Description Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.
Time Frame Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.
Arm/Group Title Trabectedin Doxorubicin Plus Ifosfamide
Hide Arm/Group Description:
Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
Overall Number of Participants Analyzed 51 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.9
(1.2 to 16.2)
27.0
(13.8 to 44.1)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.
Time Frame Baseline up to End of Study (an average of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.
Arm/Group Title Trabectedin Doxorubicin Plus Ifosfamide
Hide Arm/Group Description:
Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
Overall Number of Participants Analyzed 51 37
Median (95% Confidence Interval)
Unit of Measure: months
46.6 [1] 
(27.5 to NA)
33.5 [1] 
(21.6 to NA)
[1]
Upper limit of confidence interval was not reached because of high censorship rate that is smaller number of events.
5.Secondary Outcome
Title Duration of Response (DOR)
Hide Description The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.
Time Frame Up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Trabectedin Doxorubicin Plus Ifosfamide
Hide Arm/Group Description:
Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
Overall Number of Participants Analyzed 3 10
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(7.0 to NA)
NA [1] 
(4.4 to NA)
[1]
Median and upper confidence interval point estimates were not reached because of high censorship rate that is smaller number of events.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trabectedin Doxorubicin Plus Ifosfamide
Hide Arm/Group Description Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
All-Cause Mortality
Trabectedin Doxorubicin Plus Ifosfamide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Trabectedin Doxorubicin Plus Ifosfamide
Affected / at Risk (%) Affected / at Risk (%)
Total   24/61 (39.34%)   16/57 (28.07%) 
Blood and lymphatic system disorders     
Anemia * 1  2/61 (3.28%)  1/57 (1.75%) 
Febrile neutropenia * 1  1/61 (1.64%)  7/57 (12.28%) 
Leukopenia * 1  0/61 (0.00%)  1/57 (1.75%) 
Neutropenia * 1  2/61 (3.28%)  2/57 (3.51%) 
Thrombocytopenia * 1  2/61 (3.28%)  1/57 (1.75%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/61 (0.00%)  3/57 (5.26%) 
Duodenal perforation * 1  1/61 (1.64%)  0/57 (0.00%) 
Nausea * 1  1/61 (1.64%)  0/57 (0.00%) 
Vomiting * 1  2/61 (3.28%)  0/57 (0.00%) 
General disorders     
Chest discomfort * 1  1/61 (1.64%)  0/57 (0.00%) 
Chest pain * 1  0/61 (0.00%)  1/57 (1.75%) 
Drug withdrawal syndrome * 1  1/61 (1.64%)  0/57 (0.00%) 
Fatigue * 1  0/61 (0.00%)  1/57 (1.75%) 
Hypothermia * 1  1/61 (1.64%)  0/57 (0.00%) 
Injection site extravasation * 1  3/61 (4.92%)  0/57 (0.00%) 
Pain * 1  2/61 (3.28%)  0/57 (0.00%) 
Pyrexia * 1  3/61 (4.92%)  2/57 (3.51%) 
Hepatobiliary disorders     
Liver injury * 1  1/61 (1.64%)  0/57 (0.00%) 
Hepatocellular injury * 1  1/61 (1.64%)  0/57 (0.00%) 
Infections and infestations     
Bacteremia * 1  1/61 (1.64%)  0/57 (0.00%) 
Bronchitis viral * 1  1/61 (1.64%)  0/57 (0.00%) 
Catheter related infection * 1  4/61 (6.56%)  0/57 (0.00%) 
Device related infection * 1  3/61 (4.92%)  0/57 (0.00%) 
Erysipelas * 1  1/61 (1.64%)  0/57 (0.00%) 
Infusion site infection * 1  1/61 (1.64%)  0/57 (0.00%) 
Lower respiratory tract infection * 1  1/61 (1.64%)  0/57 (0.00%) 
Pneumococcal bacteremia * 1  0/61 (0.00%)  1/57 (1.75%) 
Pneumonia * 1  1/61 (1.64%)  2/57 (3.51%) 
Respiratory tract infection * 1  1/61 (1.64%)  0/57 (0.00%) 
Rhinitis * 1  0/61 (0.00%)  1/57 (1.75%) 
Sepsis * 1  1/61 (1.64%)  0/57 (0.00%) 
Investigations     
Blood CPK increased * 1  1/61 (1.64%)  0/57 (0.00%) 
Blood creatinine increased * 1  0/61 (0.00%)  1/57 (1.75%) 
Liver function test abnormal * 1  1/61 (1.64%)  0/57 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycemia * 1  0/61 (0.00%)  1/57 (1.75%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/61 (0.00%)  1/57 (1.75%) 
Muscular weakness * 1  1/61 (1.64%)  0/57 (0.00%) 
Myalgia * 1  1/61 (1.64%)  0/57 (0.00%) 
Rhabdomyolysis * 1  1/61 (1.64%)  0/57 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain * 1  1/61 (1.64%)  0/57 (0.00%) 
Myelodysplastic syndrome * 1  2/61 (3.28%)  0/57 (0.00%) 
Nervous system disorders     
Dyspraxia * 1  1/61 (1.64%)  0/57 (0.00%) 
Syncope vasovagal * 1  0/61 (0.00%)  1/57 (1.75%) 
Psychiatric disorders     
Mental disorder * 1  1/61 (1.64%)  1/57 (1.75%) 
Renal and urinary disorders     
Renal impairment * 1  1/61 (1.64%)  0/57 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  1/61 (1.64%)  0/57 (0.00%) 
Pulmonary embolism * 1  1/61 (1.64%)  2/57 (3.51%) 
Respiratory failure * 1  1/61 (1.64%)  0/57 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  2/61 (3.28%)  0/57 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trabectedin Doxorubicin Plus Ifosfamide
Affected / at Risk (%) Affected / at Risk (%)
Total   55/61 (90.16%)   52/57 (91.23%) 
Blood and lymphatic system disorders     
Anaemia * 1  11/61 (18.03%)  13/57 (22.81%) 
Neutropenia * 1  29/61 (47.54%)  15/57 (26.32%) 
Thrombocytopenia * 1  9/61 (14.75%)  2/57 (3.51%) 
Cardiac disorders     
Tachycardia * 1  3/61 (4.92%)  4/57 (7.02%) 
Eye disorders     
Eye irritation * 1  0/61 (0.00%)  3/57 (5.26%) 
Gastrointestinal disorders     
Abdominal distension * 1  4/61 (6.56%)  2/57 (3.51%) 
Abdominal pain * 1  8/61 (13.11%)  7/57 (12.28%) 
Abdominal pain upper * 1  8/61 (13.11%)  5/57 (8.77%) 
Constipation * 1  27/61 (44.26%)  16/57 (28.07%) 
Diarrhoea * 1  15/61 (24.59%)  15/57 (26.32%) 
Dry mouth * 1  2/61 (3.28%)  3/57 (5.26%) 
Dyspepsia * 1  8/61 (13.11%)  7/57 (12.28%) 
Haemorrhoids * 1  1/61 (1.64%)  4/57 (7.02%) 
Nausea * 1  46/61 (75.41%)  40/57 (70.18%) 
Oral pain * 1  0/61 (0.00%)  10/57 (17.54%) 
Stomatitis * 1  1/61 (1.64%)  6/57 (10.53%) 
Vomiting * 1  29/61 (47.54%)  16/57 (28.07%) 
General disorders     
Chest pain * 1  3/61 (4.92%)  3/57 (5.26%) 
Fatigue * 1  45/61 (73.77%)  42/57 (73.68%) 
Mass * 1  10/61 (16.39%)  5/57 (8.77%) 
Mucosal inflammation * 1  4/61 (6.56%)  15/57 (26.32%) 
Oedema peripheral * 1  18/61 (29.51%)  6/57 (10.53%) 
Pain * 1  2/61 (3.28%)  3/57 (5.26%) 
Pyrexia * 1  10/61 (16.39%)  11/57 (19.30%) 
Infections and infestations     
Candidiasis * 1  0/61 (0.00%)  3/57 (5.26%) 
Catheter related infection * 1  4/61 (6.56%)  0/57 (0.00%) 
Urinary tract infection * 1  2/61 (3.28%)  3/57 (5.26%) 
Investigations     
Alanine aminotransferase increased * 1  19/61 (31.15%)  1/57 (1.75%) 
Aspartate aminotransferase increased * 1  9/61 (14.75%)  0/57 (0.00%) 
Blood alkaline phosphataseincreased * 1  6/61 (9.84%)  0/57 (0.00%) 
Blood creatine phosphokinase increased * 1  4/61 (6.56%)  1/57 (1.75%) 
Gamma-glutamyltransferase increased * 1  6/61 (9.84%)  0/57 (0.00%) 
Weight decreased * 1  4/61 (6.56%)  8/57 (14.04%) 
Metabolism and nutrition disorders     
Anorexia * 1  20/61 (32.79%)  15/57 (26.32%) 
Dehydration * 1  3/61 (4.92%)  4/57 (7.02%) 
Hypocalcaemia * 1  3/61 (4.92%)  4/57 (7.02%) 
Hypokalaemia * 1  2/61 (3.28%)  4/57 (7.02%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  5/61 (8.20%)  7/57 (12.28%) 
Back pain * 1  8/61 (13.11%)  9/57 (15.79%) 
Joint range of motion decreased * 1  4/61 (6.56%)  1/57 (1.75%) 
Muscle spasms * 1  2/61 (3.28%)  3/57 (5.26%) 
Musculoskeletal pain * 1  4/61 (6.56%)  1/57 (1.75%) 
Myalgia * 1  7/61 (11.48%)  2/57 (3.51%) 
Pain in extremity * 1  6/61 (9.84%)  3/57 (5.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour pain * 1  34/61 (55.74%)  33/57 (57.89%) 
Nervous system disorders     
Dizziness * 1  5/61 (8.20%)  7/57 (12.28%) 
Dysgeusia * 1  4/61 (6.56%)  6/57 (10.53%) 
Headache * 1  13/61 (21.31%)  14/57 (24.56%) 
Neuropathy peripheral * 1  4/61 (6.56%)  0/57 (0.00%) 
Paraesthesia * 1  2/61 (3.28%)  3/57 (5.26%) 
Tremor * 1  1/61 (1.64%)  3/57 (5.26%) 
Psychiatric disorders     
Anxiety * 1  6/61 (9.84%)  4/57 (7.02%) 
Insomnia * 1  12/61 (19.67%)  6/57 (10.53%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  10/61 (16.39%)  10/57 (17.54%) 
Dyspnoea * 1  12/61 (19.67%)  6/57 (10.53%) 
Hiccups * 1  0/61 (0.00%)  4/57 (7.02%) 
Pharyngolaryngeal pain * 1  5/61 (8.20%)  2/57 (3.51%) 
Skin and subcutaneous tissue disorders     
Acne * 1  0/61 (0.00%)  3/57 (5.26%) 
Alopecia * 1  2/61 (3.28%)  25/57 (43.86%) 
Rash * 1  4/61 (6.56%)  6/57 (10.53%) 
Scar * 1  4/61 (6.56%)  2/57 (3.51%) 
Vascular disorders     
Deep vein thrombosis * 1  4/61 (6.56%)  0/57 (0.00%) 
Hypertension * 1  7/61 (11.48%)  0/57 (0.00%) 
Hypotension * 1  2/61 (3.28%)  3/57 (5.26%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Before Investigators of this study publicly disclose information, PharmaMar must be provided with at least 60 days to review and approve disclosure in order to ensure that confidential and proprietary data are protected. If PharmaMar determines that patentable patient matter is disclosed in the proposed disclosure, the latter shall be withheld for period of time considered convenient.
Results Point of Contact
Name/Title: Medical Specialist, Clinical Oncology
Organization: PharmaMar SA Av de los Reyes 1, Poligono Industrial La Mina 28770 Colmenar Viejo, Madrid, Spain
Phone: +34 91 646-6087
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00796120     History of Changes
Other Study ID Numbers: CR015769
ET-C-002-07 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
First Submitted: November 20, 2008
First Posted: November 24, 2008
Results First Submitted: March 25, 2014
Results First Posted: September 16, 2014
Last Update Posted: December 10, 2015