Phase II Study Evaluating PegLiposomal Doxorubicin (PLD) and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal Tumors

• Conditions: Gynecologic Sarcomas and Mixed Epithelial-Mesenchymal Tumors

• Registration Number: EUCTR2008-000245-55-DE
• Lead Sponsor: GYN Research GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-16
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Patients treated according to this protocol must meet all of the following 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 < 1cm) may be enrolled only if cisplatin-ifosfamide combination therapy is not feasible.
- Patients with metastatic uterine carcinosarcoma may be enrolled only if phosphamide-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 * 10^9 /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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients treated according to this protocol must not meet any of the following 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • Anticancer activity in terms of progression-free survival time (PFS)<br><br>The primary endpoint is progression free survival time (PFS) defined as the interval of time from date of enrollment to date of first documentation of progression pursuant to RECIST criteria.;Secondary Objective: • Tolerability, i.e. type, frequency, severity and duration of adverse reactions (CTCAE, Version 3.0) <br>• Anticancer activity in patients with measurable or evaluable disease in terms of response rates (CR, PR, SD, PD) according to RECIST criteria<br>• Overall survival: defined as the time from enrollment date to death date<br>• Correlation of tumor marker CA-125 with imaging methods<br>;Primary end point(s): The primary efficacy endpoint will evaluate anticancer activity in terms of progression-free survival time after 6 cycles of chemotherapy.