Trial Outcomes & Findings for Genomic Directed Salvage Chemotherapy With Either Liposomal Doxorubicin Or Topotecan (NCT NCT00720096)
NCT ID: NCT00720096
Last Updated: 2018-01-02
Results Overview
Number of patients meeting 3 week feasibility window which was set as the benchmark.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
1 year, 2 months
Results posted on
2018-01-02
Participant Flow
Participant milestones
| Measure |
Liposomal Doxorubicin
Liposomal Doxorubicin - Chemotherapy single agent systemic.
|
Topotecan
Topotecan - Chemotherapy single agent systemic.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Liposomal Doxorubicin
Liposomal Doxorubicin - Chemotherapy single agent systemic.
|
Topotecan
Topotecan - Chemotherapy single agent systemic.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Genomic Directed Salvage Chemotherapy With Either Liposomal Doxorubicin Or Topotecan
Baseline characteristics by cohort
| Measure |
Liposomal Doxorubicin
n=2 Participants
Liposomal Doxorubicin - Chemotherapy single agent systemic.
|
Topotecan
n=2 Participants
Topotecan - Chemotherapy single agent systemic.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year, 2 monthsPopulation: Patients whose information for treatment was available within the 3 week feasibility window which was set as the benchmark.
Number of patients meeting 3 week feasibility window which was set as the benchmark.
Outcome measures
| Measure |
Liposomal Doxorubicin
n=2 Participants
Liposomal Doxorubicin - Chemotherapy single agent systemic.
|
Topotecan
n=2 Participants
Topotecan - Chemotherapy single agent systemic.
|
|---|---|---|
|
Assess Feasibility
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 1 year, 2 monthsPopulation: All patients enrolled 4/4 had biopsiable tumor and sufficient quantity and quality.
Number of patients with biopsiable tumor in sufficient quantity and quality that will result in an interpretable genomic array.
Outcome measures
| Measure |
Liposomal Doxorubicin
n=2 Participants
Liposomal Doxorubicin - Chemotherapy single agent systemic.
|
Topotecan
n=2 Participants
Topotecan - Chemotherapy single agent systemic.
|
|---|---|---|
|
Interpret Genomic Array
Biopsiable tumor: sufficient quantity and quality
|
2 Participants
|
2 Participants
|
|
Interpret Genomic Array
Interpretable data
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 year, 2 monthsPopulation: Data was not collected for this Pilot study, due to small sample size and early termination.
Determine response rate of array directed chemotherapy (as defined as the proportion of patients achieving complete or partial responses with a predictive score \>/= 0.5 for either chemotherapy). As well as evaluate the accuracy of the chemosensitivity profiles for differentiating doxorubicin and topotecan responsive cancers. Due to the limited sample size the interpretation is limited. Results data for this outcome is not posted.
Outcome measures
Outcome data not reported
Adverse Events
Liposomal Doxorubicin
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Topotecan
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liposomal Doxorubicin
n=2 participants at risk
Liposomal Doxorubicin - Chemotherapy single agent systemic.
|
Topotecan
n=2 participants at risk
Topotecan - Chemotherapy single agent systemic.
|
|---|---|---|
|
Reproductive system and breast disorders
Hospital Admission
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
0.00%
0/2 • 1 year, 2 months
|
|
General disorders
Fever combined with Anemia
|
0.00%
0/2 • 1 year, 2 months
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
Other adverse events
| Measure |
Liposomal Doxorubicin
n=2 participants at risk
Liposomal Doxorubicin - Chemotherapy single agent systemic.
|
Topotecan
n=2 participants at risk
Topotecan - Chemotherapy single agent systemic.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • 1 year, 2 months
|
50.0%
1/2 • Number of events 2 • 1 year, 2 months
|
|
General disorders
Dizziness
|
0.00%
0/2 • 1 year, 2 months
|
50.0%
1/2 • Number of events 2 • 1 year, 2 months
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
|
General disorders
Headache
|
0.00%
0/2 • 1 year, 2 months
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
|
Infections and infestations
Ant bite with infection
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
0.00%
0/2 • 1 year, 2 months
|
|
Skin and subcutaneous tissue disorders
Blister on left toe
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
0.00%
0/2 • 1 year, 2 months
|
|
Skin and subcutaneous tissue disorders
Blister on right toes
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
0.00%
0/2 • 1 year, 2 months
|
|
Skin and subcutaneous tissue disorders
Blister on right toe
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
0.00%
0/2 • 1 year, 2 months
|
|
Skin and subcutaneous tissue disorders
Blister on small toe left
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
0.00%
0/2 • 1 year, 2 months
|
|
General disorders
Fever
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
0.00%
0/2 • 1 year, 2 months
|
|
Skin and subcutaneous tissue disorders
Hand foot reaction
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
0.00%
0/2 • 1 year, 2 months
|
|
Skin and subcutaneous tissue disorders
Hand foot syndrome
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
0.00%
0/2 • 1 year, 2 months
|
|
Renal and urinary disorders
Increased creatinine
|
0.00%
0/2 • 1 year, 2 months
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
|
Blood and lymphatic system disorders
Infection in blood
|
0.00%
0/2 • 1 year, 2 months
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • 1 year, 2 months
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • 1 year, 2 months
|
50.0%
1/2 • Number of events 2 • 1 year, 2 months
|
|
Skin and subcutaneous tissue disorders
Rash (chest)
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
0.00%
0/2 • 1 year, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortage of breath
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
|
General disorders
Syncope
|
0.00%
0/2 • 1 year, 2 months
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • 1 year, 2 months
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1 • 1 year, 2 months
|
0.00%
0/2 • 1 year, 2 months
|
Additional Information
Robert Wenham, M.D., via Moffitt Cancer Center
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-4933
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place