Status:
COMPLETED
Multicenter Trial With PegLiposomal Doxorubicin and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal Tumors
Lead Sponsor:
AGO Study Group
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Mesenchymal Tumor
Carcinosarcoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 di...
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 ...
Eligibility Criteria
Inclusion
- 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 \< 1cm) may be enrolled only if cisplatin-ifosfamide combination therapy is not feasible.
- Patients with metastatic uterine carcinosarcoma may be enrolled only if Ifosfamide/Paclitaxel combination therapy is not feasible.
- Patients with metastatic leiomyosarcoma may be enrolled only if gemcitabine-docetaxel combination therapy is not feasible.
- Measurable (target lesion) tumor, evaluable (non-target lesion) tumor or histological documentation
- No more than one prior chemotherapy. Any prior platinum or anthracycline- containing chemotherapy must have been completed more than 6 months previously
- Prior radiotherapy ≤ 25% of the hematopoietic system is allowed provided it took place more than 6 weeks before recruitment
- Patients are allowed to have received prior anticancer hormone therapy or specific immunotherapy. Patients must have completed these therapies at least three weeks before recruitment to the study
- All women with a theoretical possibility of pregnancy must produce a negative pregnancy test (serum or urinary) within seven days before starting treatment
- General health of 0 - 2 on the ECOG score
- At least 18 years of age
- Estimated life expectancy above 12 weeks
- At least 3 weeks since major surgery
- Appropriate hematologic, renal and hepatic function in accordance with the following definitions:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109 /l
- Platelets ≥ 100 × 10 9/l
- Total bilirubin ≤ 1.25 times upper limit of normal
- Estimated GFR ≥ 50 ml/min
- LVEF \> 50 %
- Informed consent must be obtained from all patients.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00815945
Start Date
June 1 2008
End Date
January 1 2012
Last Update
February 14 2017
Active Locations (15)
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1
Charité, Campus Virchow Klinikum, Frauenklinik
Berlin, Germany, 13353
2
Malteser Krankenhaus, Gynäkologie und Geburtshilfe
Bonn, Germany, 53123
3
Klinikum Bremen-Mitte gGmbH, Frauenklinik
Bremen, Germany, 28177
4
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Dresden, Germany, 01307