Multicenter Trial With PegLiposomal Doxorubicin and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal Tumors

Descriptive Information
Brief Title † Multicenter Trial With PegLiposomal Doxorubicin and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal Tumors
Official Title † Phase II Study Evaluating PegLiposomal Doxorubicin (PLD) and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal Tumors
Brief Summary Uterine sarcomas account for less than 5% of all carcinomas of the uterine corpus. The prognosis of these patients is extremely limited. Recurrence rates of 50-60% are reported even for early-stage disease (FIGO I/II). Median overall survival is below 12 months in patients with advanced or metastatic disease. Ovarian carcinosarcoma is extremely rare among ovarian malignancies (
Detailed Description This study in patients with mesenchymal or mixed epithelial mesenchymal tumors of the ovary or uterus is designed as a prospective single-arm, open - label, multicenter phase II study to evaluate the efficacy of PegLiposomal Doxorubicin and Carboplatin combination chemotherapy. 40 patients will be recruited to receive PegLiposomal Doxorubicin (PLD) in a continuous i. v. infusion of at least 60 minutes at a dose of 40 mg/m2 on Day 1, followed by a 30-minute i. v. carboplatin infusion according to AUC 6 (formula devised by Calvert et al). Patients will get outpatients treatment. At screening the patients' eligibility will be assessed, their baseline and demographic characteristics obtained, and baseline values for the effect variables collected. Patients with measurable lesions, non-measurable lesions or histological documentation will be included into this trial. Measurable lesion and non-measurable lesions will be documented by x-ray, ultrasound, computed tomography or MRI. The patients' safety will be monitored during therapy until recovery of toxicities. In patients with measurable lesions at baseline, the (post)-treatment values for effect according to the RECIST criteria will be collected as shown in table 6. CR, PR and SD have to be confirmed by a repeat measurement after an interval of at least four weeks. Follow-up is scheduled every three months during the first two years after the end of treatment. As from year 3 the follow-up takes place outside the study in the context of general aftercare.
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Anticancer activity in terms of progression-free survival time (PFS)
Secondary Outcome Measure † Tolerability, i.e. type, frequency, severity and duration of adverse reactions (CTCAE,Version 3.0)
Condition † Mesenchymal Tumor Carcinosarcoma Leiomyosarcoma
Intervention † DrugPegLiposomal Doxorubicin
Study Arms / Comparison Groups PegLiposomal Doxorubicin + Carboplatin Subjects will receive PegLiposomal Doxorubicin (40mg/m²) and Carboplatin (AUC6) every 28 days. Treatment period up to 6 months (therapy can be continued in case of tumor response and benefit for the patient)
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 41
Start Date † June 2008
Completion Date January 2012
Primary Completion Date November 2011
Eligibility Criteria † Inclusion Criteria: - Histologically documented mesenchymal or mixed epithelial-mesenchymal tumor of the ovary or uterus - Patients with a primary diagnosis of FIGO I-IV uterine carcinosarcoma and optimum debulking (postoperative residual tumor 50 % - Informed consent must be obtained from all patients. Exclusion Criteria: - More than one prior chemotherapy (or radiochemotherapy) - Active infection or other serious medical impairment liable to affect the patient's ability to receive treatment according to protocol. - Administration of other chemotherapy drugs or other anticancer hormone treatments during the study. - History of clinically manifest atrial or ventricular arrhythmia (> LOWN II) and congestive heart failure, even if controlled by drugs (NYHA class > II). Documented myocardial infarction within 6 months before study enrollment. - Pregnant or breastfeeding women, or women not practicing appropriate birth control methods - Participation in another study using experimental drugs within the last 30 days - Any other conditions or therapies which the physician believes might put the patient at risk or impair the study objective. - Known hypersensitivity to carboplatin or pegylated liposomal doxorubicin
Gender Female
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Germany
Administrative Information
NCT ID † NCT00815945
Organization ID AGO-GYN 7
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † AGO Study Group
Collaborators †† MSD SHARP & DOHME GmbH (formerly Essex Pharma GmbH)
Investigators † Principal Investigator: Philipp Harter, MD, Klinikum Essen Mitte
Information Provided By
Verification Date March 2014
First Received Date † December 30, 2008
Last Updated Date February 13, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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