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Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00170573
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : March 25, 2016
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology

Brief Summary:
Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Caelyx Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2001
Actual Primary Completion Date : April 2009
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: Caelyx Drug: Caelyx
Caelyx 40 mg/ m2biweekly

Primary Outcome Measures :
  1. Toxicity [ Time Frame: Toxicity ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Overall survival ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00170573

Sponsors and Collaborators
North Eastern Germany Society of Gynaecologic Oncology
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Principal Investigator: Jalid Sehouli Charite University, Berlin, Germany

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Responsible Party: North Eastern Germany Society of Gynaecologic Oncology Identifier: NCT00170573     History of Changes
Other Study ID Numbers: 32005000
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Keywords provided by North Eastern Germany Society of Gynaecologic Oncology:
biweekly schedule of PLD - Ovarian cancer - pegylated liposomal doxorubicin -quality of life - Toxic skin reactions
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action