Trial Outcomes & Findings for Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer (NCT NCT00170573)
NCT ID: NCT00170573
Last Updated: 2024-12-16
Results Overview
The outcome will be measured by number of participants with reported skin toxicity PPE of CTC (Common Toxicity Criteria)-Grade I / II / III / IV. Grade I - Dysesthesia/paraesthesia tingling of hands and feet; Grade II - Discomfort in holding objects and upon walking, painless swelling and erythema; Grade III - painful erythema and swelling of palms and soles, periungual erythema and swelling; Grade IV - Desquamation, ulceration, blistering, severe pain
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
through study completion, an average of 18 months
Results posted on
2024-12-16
Participant Flow
recruitment period: September 2001 - February 2004
Participant milestones
| Measure |
Caelyx
40 mg/m² biweekly
|
|---|---|
|
Overall Study
STARTED
|
77
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Caelyx
40 mg/m² biweekly
|
|---|---|
|
Overall Study
Violation of inclusion criteria
|
13
|
Baseline Characteristics
Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Caelyx
n=64 Participants
Caelyx: Caelyx 40 mg/ m2biweekly
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
64 participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IA
|
2 participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IB
|
0 participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IC
|
1 participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IIA
|
8 participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IIB
|
2 participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IIC
|
4 participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IIIA
|
2 participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IIIB
|
3 participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IIIC
|
34 participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
stage IV
|
7 participants
n=5 Participants
|
|
Classification of tumour (according to FIGO ovarian cancer staging)
unknown
|
1 participants
n=5 Participants
|
|
Histological grade
grade 1
|
8 participants
n=5 Participants
|
|
Histological grade
grade 2
|
20 participants
n=5 Participants
|
|
Histological grade
grade 3
|
28 participants
n=5 Participants
|
|
Histological grade
grade 4
|
0 participants
n=5 Participants
|
|
Histological grade
unknown
|
8 participants
n=5 Participants
|
|
ECOG performance status
0
|
20 participants
n=5 Participants
|
|
ECOG performance status
1
|
34 participants
n=5 Participants
|
|
ECOG performance status
2
|
10 participants
n=5 Participants
|
|
ECOG performance status
3
|
0 participants
n=5 Participants
|
|
ECOG performance status
4
|
0 participants
n=5 Participants
|
|
ECOG performance status
5
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 18 monthsThe outcome will be measured by number of participants with reported skin toxicity PPE of CTC (Common Toxicity Criteria)-Grade I / II / III / IV. Grade I - Dysesthesia/paraesthesia tingling of hands and feet; Grade II - Discomfort in holding objects and upon walking, painless swelling and erythema; Grade III - painful erythema and swelling of palms and soles, periungual erythema and swelling; Grade IV - Desquamation, ulceration, blistering, severe pain
Outcome measures
| Measure |
Caelyx
n=64 Participants
Caelyx: Caelyx 40 mg/ m2biweekly
|
|---|---|
|
Occurrence of Palmar-plantar Erythrodysesthesia (PPE)
CTC-Grade I
|
18 Participants
|
|
Occurrence of Palmar-plantar Erythrodysesthesia (PPE)
CTC-Grade II
|
9 Participants
|
|
Occurrence of Palmar-plantar Erythrodysesthesia (PPE)
CTC-Grade III
|
3 Participants
|
|
Occurrence of Palmar-plantar Erythrodysesthesia (PPE)
CTC-Grade IV
|
0 Participants
|
|
Occurrence of Palmar-plantar Erythrodysesthesia (PPE)
no PPE
|
34 Participants
|
SECONDARY outcome
Timeframe: for up to 3 yearsOverall survival estimated by the Kaplan-Meier method
Outcome measures
| Measure |
Caelyx
n=64 Participants
Caelyx: Caelyx 40 mg/ m2biweekly
|
|---|---|
|
Overall Survival
|
18.2 months
Interval 1.4 to 34.0
|
Adverse Events
Caelyx
Serious events: 4 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caelyx
n=64 participants at risk
40 mg/m² biweekly
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.7%
3/64 • through study completion, an average of 18 months
Patients were asked at each visit for the occurrence of adverse events. Furthermore blood samples for hematological and clinical chemistry assessment were taken at defined time points.
|
|
Blood and lymphatic system disorders
Thrombopenia
|
1.6%
1/64 • through study completion, an average of 18 months
Patients were asked at each visit for the occurrence of adverse events. Furthermore blood samples for hematological and clinical chemistry assessment were taken at defined time points.
|
Other adverse events
| Measure |
Caelyx
n=64 participants at risk
40 mg/m² biweekly
|
|---|---|
|
Blood and lymphatic system disorders
Leucopenia
|
40.6%
26/64 • through study completion, an average of 18 months
Patients were asked at each visit for the occurrence of adverse events. Furthermore blood samples for hematological and clinical chemistry assessment were taken at defined time points.
|
|
Skin and subcutaneous tissue disorders
PPE
|
46.9%
30/64 • through study completion, an average of 18 months
Patients were asked at each visit for the occurrence of adverse events. Furthermore blood samples for hematological and clinical chemistry assessment were taken at defined time points.
|
|
Blood and lymphatic system disorders
Thrombopenia
|
6.2%
4/64 • through study completion, an average of 18 months
Patients were asked at each visit for the occurrence of adverse events. Furthermore blood samples for hematological and clinical chemistry assessment were taken at defined time points.
|
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