Ovarian Cancer
Conditions
Keywords
Pegylated liposomal doxorubicin, PPE, Ovarian Cancer
Brief summary
Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life
Detailed description
Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions e.g. palmar-plantar erythrodysesthesia (PPE) were reported as being the dose-limiting toxicity and have an impact on patients' quality of life (QoL). The primary aim of this study was to optimise the toxicity profile by choosing a biweekly schedule of PLD Furthermore, QoL was investigated. Secondary objective of this study was to evaluate the response rates of this new regimen.
Interventions
DRUGCaelyx
40 mg/m² biweekly
Sponsors
North Eastern German Society of Gynaecological Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years of age * recurrent ovarian, peritoneal, or tubal cancer and prior treatment with platinum- and paclitaxel were eligible to this trial. * Eastern Cooperative Oncology Group (ECOG) performance status less than 3. * renal function (serum creatinine 1.25 times the upper limit of normal, glomerular filtration rate greater than 60 ml/min) * liver function (AST/ ALT three times the upper limit of normal, bilirubin concentrations 1.25 the upper limit of normal) * bone marrow function (neutrophil count greater than 1.5 x 109/l, and a platelet count greater than 100 x 109/l).
Exclusion criteria
* patients with more than 4 chemotherapies in medical history * severe cardiac disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Palmar-plantar Erythrodysesthesia (PPE) | through study completion, an average of 18 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | for up to 3 years | Overall survival estimated by the Kaplan-Meier method |
Participant flow
Recruitment details
recruitment period: September 2001 - February 2004
Participants by arm
| Arm | Count |
|---|---|
| Caelyx Caelyx: Caelyx 40 mg/ m2biweekly | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Violation of inclusion criteria | 13 |
Baseline characteristics
| Characteristic | Caelyx |
|---|---|
| Age, Continuous | 59 years |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IA | 2 participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IB | 0 participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IC | 1 participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IIA | 8 participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IIB | 2 participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IIC | 4 participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IIIA | 2 participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IIIB | 3 participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IIIC | 34 participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IV | 7 participants |
| Classification of tumour (according to FIGO ovarian cancer staging) unknown | 1 participants |
| ECOG performance status 0 | 20 participants |
| ECOG performance status 1 | 34 participants |
| ECOG performance status 2 | 10 participants |
| ECOG performance status 3 | 0 participants |
| ECOG performance status 4 | 0 participants |
| ECOG performance status 5 | 0 participants |
| Histological grade grade 1 | 8 participants |
| Histological grade grade 2 | 20 participants |
| Histological grade grade 3 | 28 participants |
| Histological grade grade 4 | 0 participants |
| Histological grade unknown | 8 participants |
| Region of Enrollment Germany | 64 participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 60 / 64 |
| serious Total, serious adverse events | 4 / 64 |
Outcome results
Primary
Occurrence of Palmar-plantar Erythrodysesthesia (PPE)
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
Time frame: through study completion, an average of 18 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Caelyx | Occurrence of Palmar-plantar Erythrodysesthesia (PPE) | CTC-Grade I | 18 Participants |
| Caelyx | Occurrence of Palmar-plantar Erythrodysesthesia (PPE) | CTC-Grade II | 9 Participants |
| Caelyx | Occurrence of Palmar-plantar Erythrodysesthesia (PPE) | CTC-Grade III | 3 Participants |
| Caelyx | Occurrence of Palmar-plantar Erythrodysesthesia (PPE) | CTC-Grade IV | 0 Participants |
| Caelyx | Occurrence of Palmar-plantar Erythrodysesthesia (PPE) | no PPE | 34 Participants |
Secondary
Overall Survival
Overall survival estimated by the Kaplan-Meier method
Time frame: for up to 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Caelyx | Overall Survival | 18.2 months |