Trial Outcomes & Findings for Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer (NCT NCT00170625)
NCT ID: NCT00170625
Last Updated: 2024-11-12
Results Overview
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
28 participants
Primary outcome timeframe
after each cycle for up to one year
Results posted on
2024-11-12
Participant Flow
Recruitment period: 2.6.2004 - 30.8.2005
2 patients missed the inclusion criteria
Participant milestones
| Measure |
Relapse 6-12 Months
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
|
Relapse >12 Months
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Relapse 6-12 Months
n=13 Participants
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
|
Relapse >12 Months
n=13 Participants
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
63 years
n=7 Participants
|
61.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 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
Germany
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IA
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IB
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IC
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IIA
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IIB
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IIC
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IIIA
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IIIB
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IIIC
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IV
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after each cycle for up to one yearA DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
Outcome measures
| Measure |
Relapse 6-12 Months
n=13 Participants
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
|
Relapse >12 Months
n=13 Participants
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
|
|---|---|---|
|
Occurrence of a DLT (Dose Limiting Toxicity)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: after every third cycle, for up to one yearProgression-free survival according to kaplan-meier-estimator
Outcome measures
| Measure |
Relapse 6-12 Months
n=13 Participants
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
|
Relapse >12 Months
n=13 Participants
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
7.3 months
Interval 1.3 to 14.0
|
8.4 months
Interval 1.9 to 18.1
|
Adverse Events
Relapse 6-12 Months
Serious events: 6 serious events
Other events: 10 other events
Deaths: 4 deaths
Relapse>12 Months
Serious events: 6 serious events
Other events: 7 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Relapse 6-12 Months
n=13 participants at risk
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
|
Relapse>12 Months
n=13 participants at risk
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
|
|---|---|---|
|
Immune system disorders
allergic reaction
|
0.00%
0/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
7.7%
1/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
|
Blood and lymphatic system disorders
anemia
|
15.4%
2/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
7.7%
1/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
30.8%
4/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
30.8%
4/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
Other adverse events
| Measure |
Relapse 6-12 Months
n=13 participants at risk
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
|
Relapse>12 Months
n=13 participants at risk
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
30.8%
4/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
15.4%
2/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
15.4%
2/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
|
Gastrointestinal disorders
Emesis
|
7.7%
1/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
7.7%
1/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
|
Gastrointestinal disorders
Constipation
|
23.1%
3/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
0.00%
0/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
15.4%
2/13 • Until 6 months after 4th study cycle
At each visits patients were asked for the occurence of adverse events and blood samples for laboratory assessment were taken in addition.
|
Additional Information
Prof. Dr. Jalid Sehouli
Charite Campus Vichow Klinikum
Phone: +49 30-450564052
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60