Trial Outcomes & Findings for Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma (NCT NCT00586846)
NCT ID: NCT00586846
Last Updated: 2016-01-20
Results Overview
to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
2 years
Results posted on
2016-01-20
Participant Flow
Participant milestones
| Measure |
All Patients
Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
All Patients
Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Evaluable for Toxicity Only
|
4
|
Baseline Characteristics
Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
Baseline characteristics by cohort
| Measure |
All Patients
n=40 Participants
Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
|
|---|---|
|
Age, Categorical
<=18 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsto the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).
Outcome measures
| Measure |
All Patients
n=34 Participants
Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
|
|---|---|
|
Radiographic Response
Partial Response (PR)
|
5 participants
|
|
Radiographic Response
Stable Disease (SD)
|
5 participants
|
|
Radiographic Response
Complete Response (CR)
|
21 participants
|
|
Radiographic Response
Progression of Disease (POD)
|
3 participants
|
Adverse Events
All Patients
Serious events: 25 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=40 participants at risk
Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
|
|---|---|
|
Metabolism and nutrition disorders
Calcium, low (hypocalcemia)
|
7.5%
3/40 • Number of events 3
|
|
Metabolism and nutrition disorders
Creatinine
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Febrile neutropenia
|
10.0%
4/40 • Number of events 9
|
|
General disorders
Fever (in the absence of neutropenia)
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
7.5%
3/40 • Number of events 3
|
|
Infections and infestations
Skin infection
|
2.5%
1/40 • Number of events 2
|
|
Reproductive system and breast disorders
Intraoperative reproductive tract
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic/Lab - Other
|
5.0%
2/40 • Number of events 2
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
5.0%
2/40 • Number of events 2
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
10.0%
4/40 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis/thrombus/embolism
|
2.5%
1/40 • Number of events 2
|
Other adverse events
| Measure |
All Patients
n=40 participants at risk
Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
42.5%
17/40 • Number of events 17
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
5.0%
2/40 • Number of events 2
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
92.5%
37/40 • Number of events 37
|
|
General disorders
Anorexia
|
20.0%
8/40 • Number of events 8
|
|
Metabolism and nutrition disorders
AST, SGOT
|
92.5%
37/40 • Number of events 37
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
47.5%
19/40 • Number of events 19
|
|
Metabolism and nutrition disorders
Calcium, low (hypocalcemia)
|
40.0%
16/40 • Number of events 16
|
|
Gastrointestinal disorders
Constipation
|
17.5%
7/40 • Number of events 7
|
|
Gastrointestinal disorders
Dehydration
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
10.0%
4/40 • Number of events 4
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
10.0%
4/40 • Number of events 4
|
|
General disorders
Febrile neutropenia
|
62.5%
25/40 • Number of events 25
|
|
General disorders
Fever (in the absence of neutropenia)
|
17.5%
7/40 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Flushing
|
7.5%
3/40 • Number of events 3
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
97.5%
39/40 • Number of events 39
|
|
Metabolism and nutrition disorders
Glucose, low (hypoglycemia)
|
15.0%
6/40 • Number of events 6
|
|
General disorders
Hair loss/alopecia (scalp or body)
|
35.0%
14/40 • Number of events 14
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
40/40 • Number of events 40
|
|
General disorders
Hemorrhage, Nose
|
10.0%
4/40 • Number of events 4
|
|
Cardiac disorders
Hypertension
|
5.0%
2/40 • Number of events 2
|
|
Infections and infestations
Catheter Related Infection
|
15.0%
6/40 • Number of events 9
|
|
Infections and infestations
Infection, other
|
5.0%
2/40 • Number of events 2
|
|
Blood and lymphatic system disorders
International Normalized Ratio (INR)
|
7.5%
3/40 • Number of events 3
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
40/40 • Number of events 40
|
|
Blood and lymphatic system disorders
Lymphopenia
|
82.5%
33/40 • Number of events 33
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
42.5%
17/40 • Number of events 17
|
|
Metabolism and nutrition disorders
Metabolic/Lab - Other
|
10.0%
4/40 • Number of events 4
|
|
General disorders
Mucositis (Clincal exam)- Oral cavity
|
57.5%
23/40 • Number of events 23
|
|
General disorders
Mucositis (Clincal exam)- Pharynx
|
7.5%
3/40 • Number of events 3
|
|
General disorders
Mucositis (symptoms)- Oral cavity
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
47.5%
19/40 • Number of events 19
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
40/40 • Number of events 40
|
|
General disorders
Pain - Abdomen NOS
|
5.0%
2/40 • Number of events 2
|
|
General disorders
Pain - Back
|
5.0%
2/40 • Number of events 2
|
|
General disorders
Pain - Dental/teeth/peridontal
|
5.0%
2/40 • Number of events 2
|
|
General disorders
Pain - Extremity-limb
|
17.5%
7/40 • Number of events 7
|
|
General disorders
Pain - Head/headache
|
5.0%
2/40 • Number of events 2
|
|
General disorders
Pain - Other
|
25.0%
10/40 • Number of events 10
|
|
General disorders
Pain - Throat/pharynx/larynx
|
5.0%
2/40 • Number of events 2
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
95.0%
38/40 • Number of events 38
|
|
Blood and lymphatic system disorders
Platelets
|
97.5%
39/40 • Number of events 39
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
2/40 • Number of events 2
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
32.5%
13/40 • Number of events 13
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
42.5%
17/40 • Number of events 17
|
|
Blood and lymphatic system disorders
Partial thromboplastin time (PTT)
|
30.0%
12/40 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.5%
3/40 • Number of events 3
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
45.0%
18/40 • Number of events 18
|
|
General disorders
Tinnitus
|
27.5%
11/40 • Number of events 11
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
20/40 • Number of events 20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place