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

Phase 2
18 Years
Open (Enrolling)
Mesenchymal Tumor, Carcinosarcoma, Leiomyosarcoma

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Trial Information

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

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

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

As from year 3 the follow-up takes place outside the study in the context of general

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 < 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

- 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

- 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 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Anticancer activity in terms of progression-free survival time (PFS)

Outcome Time Frame:

every 3 months

Safety Issue:


Principal Investigator

Philipp Harter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinikum Essen Mitte


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

June 2008

Completion Date:

June 2013

Related Keywords:

  • Mesenchymal Tumor
  • Carcinosarcoma
  • Leiomyosarcoma
  • leiomyosarcoma
  • carcinosarcoma
  • mixed epithelial mesenchymal tumor
  • endometrial stroma sarcomas
  • Müllerian mixed tumors
  • carcinosarcoma of the uterus
  • mesenchymal tumors of the ovary or uterus
  • mixed epithelial mesenchymal tumors of the ovary or uterus
  • Carcinosarcoma
  • Mixed Tumor, Mullerian
  • Leiomyosarcoma
  • Sarcoma