Trial Outcomes & Findings for Combination Chemotherapy and Dexrazoxane Followed by Surgery and Radiation Therapy in Treating Patients With Advanced Soft Tissue Sarcoma or Recurrent Bone Sarcoma (NCT NCT00544778)
NCT ID: NCT00544778
Last Updated: 2014-08-28
Results Overview
Response rate defined as the proportion of subjects with confirmed partial or complete response as defined by the RECIST criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
First disease evaluation one month after the start of treatment and every 3 months there after, up to 2 years.
Results posted on
2014-08-28
Participant Flow
Participant milestones
| Measure |
Arm 1
High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy and Dexrazoxane Followed by Surgery and Radiation Therapy in Treating Patients With Advanced Soft Tissue Sarcoma or Recurrent Bone Sarcoma
Baseline characteristics by cohort
| Measure |
Arm 1
n=7 Participants
High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
|
|---|---|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
|
Age, Continuous
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First disease evaluation one month after the start of treatment and every 3 months there after, up to 2 years.Response rate defined as the proportion of subjects with confirmed partial or complete response as defined by the RECIST criteria.
Outcome measures
| Measure |
Arm 1
n=7 Participants
High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
|
|---|---|
|
Response Rate
|
0 percentage of patients responding
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1
n=7 participants at risk
High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
57.1%
4/7 • Number of events 5 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
85.7%
6/7 • Number of events 21 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Blood and lymphatic system disorders
Packed red blood cell transfusion
|
42.9%
3/7 • Number of events 5 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
42.9%
3/7 • Number of events 5 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Eye disorders
Vision blurred
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
57.1%
4/7 • Number of events 4 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Constipation
|
57.1%
4/7 • Number of events 6 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
3/7 • Number of events 4 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
57.1%
4/7 • Number of events 5 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Esophagitis
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Haematochezia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Incontinence NOS
|
28.6%
2/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Melaena
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
28.6%
2/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • Number of events 17 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
85.7%
6/7 • Number of events 11 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
General disorders
Chest pain
|
28.6%
2/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
General disorders
Chills
|
28.6%
2/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
General disorders
Fatigue
|
85.7%
6/7 • Number of events 22 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
General disorders
Oedema NOS
|
28.6%
2/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
General disorders
Pain
|
57.1%
4/7 • Number of events 8 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Infections and infestations
Catheter related infection
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Infections and infestations
Infection NOS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
42.9%
3/7 • Number of events 4 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
57.1%
4/7 • Number of events 9 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
71.4%
5/7 • Number of events 12 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Investigations
Creatinine increased
|
28.6%
2/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Investigations
Hyperbilirubinemia
|
28.6%
2/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Investigations
INR increased
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Investigations
Leukopenia
|
28.6%
2/7 • Number of events 4 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Investigations
Lymphopenia
|
42.9%
3/7 • Number of events 8 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Investigations
Neutrophil count decreased
|
28.6%
2/7 • Number of events 3 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Investigations
Platelet count decreased
|
28.6%
2/7 • Number of events 3 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Investigations
Weight loss
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
57.1%
4/7 • Number of events 6 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
85.7%
6/7 • Number of events 11 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
85.7%
6/7 • Number of events 18 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
57.1%
4/7 • Number of events 9 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
71.4%
5/7 • Number of events 10 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
28.6%
2/7 • Number of events 3 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
85.7%
6/7 • Number of events 9 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
28.6%
2/7 • Number of events 5 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.6%
2/7 • Number of events 4 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Nervous system disorders
Depressed level of consciousness
|
14.3%
1/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Nervous system disorders
Extrapyramidal disorder
|
28.6%
2/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • Number of events 3 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
85.7%
6/7 • Number of events 12 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • Number of events 6 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Psychiatric disorders
Anxiety
|
28.6%
2/7 • Number of events 3 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Psychiatric disorders
Confusion
|
42.9%
3/7 • Number of events 5 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Psychiatric disorders
Depression
|
28.6%
2/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Psychiatric disorders
Hallucination NOS
|
28.6%
2/7 • Number of events 3 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Psychiatric disorders
Insomnia
|
28.6%
2/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Renal and urinary disorders
Bladder pain
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
2/7 • Number of events 3 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
28.6%
2/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
14.3%
1/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
14.3%
1/7 • Number of events 2 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
|
Vascular disorders
Hypotension
|
42.9%
3/7 • Number of events 5 • Adverse events were collected over a period of 11 months.
"Other" adverse events are all grades and attributions to treatment not included in "Serious" adverse events.
|
Additional Information
Paul Frankel, Ph. D.
City of Hope National Medical Center
Phone: (626)359-8111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place