Trial Outcomes & Findings for Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma (NCT NCT00470275)
NCT ID: NCT00470275
Last Updated: 2014-10-20
Results Overview
Any patient who is enrolled and receives at least one dose of cytarabine will be considered evaluable for response if (1) the patient demonstrates progressive disease while on protocol therapy or (2) the patient is observed on protocol therapy for at least one cycle. Patients who achieve a complete or partial response according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.
COMPLETED
PHASE2
10 participants
the first six cycles of study chemotherapy (126 days)
2014-10-20
Participant Flow
Participant milestones
| Measure |
Cytarbine
Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Cytarbine
Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma
Baseline characteristics by cohort
| Measure |
Cytarbine
n=10 Participants
Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: the first six cycles of study chemotherapy (126 days)Any patient who is enrolled and receives at least one dose of cytarabine will be considered evaluable for response if (1) the patient demonstrates progressive disease while on protocol therapy or (2) the patient is observed on protocol therapy for at least one cycle. Patients who achieve a complete or partial response according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.
Outcome measures
| Measure |
Cytarabine
n=10 Participants
Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
|
|---|---|
|
Response
Non Responder
|
10 participants
|
|
Response
Responder
|
0 participants
|
Adverse Events
Cytarabine
Serious adverse events
| Measure |
Cytarabine
n=10 participants at risk
Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10
|
|
Investigations
Platelet count decreased
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
10.0%
1/10
|
Other adverse events
| Measure |
Cytarabine
n=10 participants at risk
Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
4/10
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10
|
|
Immune system disorders
Anaphylaxis
|
10.0%
1/10
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
5/10
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
2/10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.0%
1/10
|
|
General disorders
Chills
|
10.0%
1/10
|
|
Infections and infestations
Conjunctivitis infective
|
10.0%
1/10
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10
|
|
Investigations
Creatinine increased
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10
|
|
Gastrointestinal disorders
Esophageal pain
|
10.0%
1/10
|
|
Gastrointestinal disorders
Esophagitis
|
10.0%
1/10
|
|
Eye disorders
Eye disorders - Other
|
10.0%
1/10
|
|
General disorders
Facial pain
|
10.0%
1/10
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
40.0%
4/10
|
|
General disorders
Fever
|
20.0%
2/10
|
|
Nervous system disorders
Headache
|
10.0%
1/10
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.0%
3/10
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
1/10
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
1/10
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
2/10
|
|
Infections and infestations
Infections and infestations - Other
|
50.0%
5/10
|
|
Investigations
Lymphocyte count decreased
|
30.0%
3/10
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10
|
|
Nervous system disorders
Nervous system disorders - Other
|
10.0%
1/10
|
|
Investigations
Neutrophil count decreased
|
80.0%
8/10
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
1/10
|
|
General disorders
Pain
|
10.0%
1/10
|
|
Eye disorders
Photophobia
|
10.0%
1/10
|
|
Investigations
Platelet count decreased
|
80.0%
8/10
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
10.0%
1/10
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10
|
|
Investigations
White blood cell decreased
|
40.0%
4/10
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER