Trial Outcomes & Findings for Oxaliplatin and Topotecan in Advance Ovarian Cancer (NCT NCT00313612)
NCT ID: NCT00313612
Last Updated: 2015-11-27
Results Overview
Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Every two cycles for up to 24 weeks.
Results posted on
2015-11-27
Participant Flow
A total of 39 patients were enrolled from 3 institutions between January 2006 and October 2009
1 patient never received treatment
Participant milestones
| Measure |
Treatment Stratum I (Oxaliplatin Plus Topotecan)
Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
Treatment Stratum II (Oxaliplatin Plus Topotecan)
Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Treatment Stratum I (Oxaliplatin Plus Topotecan)
Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
Treatment Stratum II (Oxaliplatin Plus Topotecan)
Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
|---|---|---|
|
Overall Study
Patient never received treatment
|
0
|
1
|
Baseline Characteristics
Oxaliplatin and Topotecan in Advance Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Treatment Stratum I: (Oxaliplatin Plus Topotecan)
n=19 Participants
Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
Treatment Stratum II (Oxaliplatin Plus Topotecan)
n=20 Participants
Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
59 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every two cycles for up to 24 weeks.Population: 30 patients were analyzed. Eight patients discontinued treatment before 2 cycles.
Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment Stratum I (Oxaliplatin Plus Topotecan)
n=16 Participants
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
Treatment Stratum II (Oxaliplatin Plus Topotecan)
n=14 Participants
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
|---|---|---|
|
Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)
Complete Response
|
3 participants
|
3 participants
|
|
Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)
Partial Response
|
1 participants
|
6 participants
|
|
Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)
Stable Disease
|
8 participants
|
4 participants
|
|
Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)
Disease Progression
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeksTime to disease progression by RECIST and/or CA 125
Outcome measures
| Measure |
Treatment Stratum I (Oxaliplatin Plus Topotecan)
n=19 Participants
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
Treatment Stratum II (Oxaliplatin Plus Topotecan)
n=19 Participants
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
|---|---|---|
|
Time to Disease Progression by RECIST and/or CA 125
|
6.3 months
Interval 2.6 to 7.1
|
12.6 months
Interval 4.3 to 16.2
|
Adverse Events
Treatment Stratum I (Oxaliplatin Plus Topotecan)
Serious events: 14 serious events
Other events: 18 other events
Deaths: 0 deaths
Treatment Stratum II (Oxaliplatin Plus Topotecan)
Serious events: 12 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Stratum I (Oxaliplatin Plus Topotecan)
n=19 participants at risk
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
Treatment Stratum II (Oxaliplatin Plus Topotecan)
n=19 participants at risk
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
|---|---|---|
|
Investigations
Neutropenia
|
15.8%
3/19 • Number of events 3
|
63.2%
12/19 • Number of events 12
|
|
Blood and lymphatic system disorders
Anemia
|
21.1%
4/19 • Number of events 4
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
RBC transfusion
|
21.1%
4/19 • Number of events 4
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Thrombocytopenia
|
26.3%
5/19 • Number of events 5
|
52.6%
10/19 • Number of events 10
|
|
Investigations
Platelet transfusion
|
5.3%
1/19 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Alanine aminotransferase
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Investigations
Aspartate aminotransferase
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
Other adverse events
| Measure |
Treatment Stratum I (Oxaliplatin Plus Topotecan)
n=19 participants at risk
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
Treatment Stratum II (Oxaliplatin Plus Topotecan)
n=19 participants at risk
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
21.1%
4/19 • Number of events 4
|
21.1%
4/19 • Number of events 4
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
47.4%
9/19 • Number of events 9
|
84.2%
16/19 • Number of events 16
|
|
Metabolism and nutrition disorders
Anorexia
|
52.6%
10/19 • Number of events 10
|
36.8%
7/19 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.8%
3/19 • Number of events 3
|
26.3%
5/19 • Number of events 5
|
|
Investigations
Weight loss
|
15.8%
3/19 • Number of events 3
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/19
|
15.8%
3/19 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
47.4%
9/19 • Number of events 9
|
94.7%
18/19 • Number of events 18
|
|
Nervous system disorders
Headache
|
0.00%
0/19
|
26.3%
5/19 • Number of events 5
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/19
|
15.8%
3/19 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
21.1%
4/19 • Number of events 4
|
26.3%
5/19 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60