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Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caelyx | Experimental | 40 mg/m² biweekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caelyx | Drug | 40 mg/m² biweekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival estimated by the Kaplan-Meier method | for up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jalid Sehouli | Charite University, Berlin, Germany | Principal Investigator |
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recruitment period: September 2001 - February 2004
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| ID | Title | Description |
|---|---|---|
| FG000 | Caelyx | 40 mg/m² biweekly |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caelyx | Caelyx: Caelyx 40 mg/ m2biweekly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | through study completion, an average of 18 months |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caelyx | 40 mg/m² biweekly |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leucopenia | Blood and lymphatic system disorders | NCI 2 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Jalid Sehouli | Charite Campus Vichow Klinikum | +49 30-450564052 | jalid.sehouli@charite.de |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Classification of tumour (according to FIGO ovarian cancer staging) | IA - Tumor limited to one ovary, IB - Tumor limited to both ovaries, IC - Tumor involves 1 or both ovaries + capsule rupture, tumor on surface or positive washings/ascites, IIA - Extension and/or implants on the uterus and/or tube(s), IIB - Extension to other pelvic intraperitoneal tissues, IIC - IIA or IIB with positive washings/ascites, IIIA - Microscopic peritoneal metastasis beyond the pelvis, IIIB - Macroscopic, extrapelvic, peritoneal metastasis ≤ 2 cm, IIIC - Macroscopic, extrapelvic, peritoneal metastasis > 2 cm and/or regional lymph node metastasis, IV - Distant metastasis | Number | participants |
|
| Histological grade | grade 1 - well differentiated; grade 2 - moderately differentiated; grade 3 - poorly differentiated; grade 4 - undifferentiated Lower grade tumours generally grow more slowly and are less likely to spread and metastasize than higher grade tumours. | Number | participants |
|
| ECOG performance status | 0 - Fully active, able to carry on all pre-disease performance without restriction; 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities, up and about more than 50% of waking hours; 3 - Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 - Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 - Dead | Number | participants |
|
| Participants |
|
|
| Secondary | Overall Survival | Overall survival estimated by the Kaplan-Meier method | Posted | Median | Full Range | months | for up to 3 years |
|
|
|
| 4 |
| 64 |
| 60 |
| 64 |
| Thrombopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| PPE | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Thrombopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |