Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer
Comparison of Quality of Life in Patients With Platinum-sensitive Recurrent Ovarian, Fallopian Tube and Peritoneal Cancer When Treated With Treatment With Trabectedin/PLD or Standard Platinum-based Therapy
1 other identifier
interventional
77
0 countries
N/A
Brief Summary
Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 ovarian-cancer
Started Sep 2001
Longer than P75 for phase_2 ovarian-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
December 16, 2024
CompletedDecember 16, 2024
November 1, 2024
7.6 years
September 9, 2005
October 4, 2016
November 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Overall Survival
for up to 3 years
Study Arms (1)
Caelyx
EXPERIMENTAL40 mg/m² biweekly
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- patients with more than 4 chemotherapies in medical history
- severe cardiac disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Dr. Jalid Sehouli
- Organization
- Charite Campus Vichow Klinikum
Study Officials
- PRINCIPAL INVESTIGATOR
Jalid Sehouli
Charite University, Berlin, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
September 1, 2001
Primary Completion
April 1, 2009
Study Completion
August 1, 2010
Last Updated
December 16, 2024
Results First Posted
December 16, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share