Leiomyosarcoma Clinical Trial
Official title:
Phase II Study Evaluating PegLiposomal Doxorubicin (PLD) and Carboplatin Combination Chemotherapy in Gynecological Sarcomas and Mixed Epithelial-Mesenchymal Tumors
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 (< 2%). That is why
there is insufficient data as a basis for establishing a gold standard. As a result, these
cases tend to be treated in the same way as uterine sarcomas or epithelial ovarian
malignancies in clinical practice.
On the basis of data published to date on the treatment of mixed mesenchymal-epithelial
tumors, it is clear that the treatments commonly used to date have limited activity while
producing clinically relevant toxicity. The regimes verified so far (Cisplatin / Ifosfamide,
Ifosfamide/Paclitaxel and Gemcitabine/Docetaxel) exhibit a considerable side effect spectrum
and are only rarely feasible on clinical everyday life conditions, so e. g. the rate of
withdrawals due to toxicity was in a study collective of selected females treated with the
last combination at 40 %. The physician has to check in every individual case if one of the
above mentioned combinations is feasible. The search for alternative effective and better
tolerated treatment options is essential. The toxicity data on the carboplatin-PLD
combination are known, and efficacy has been identified in small cohorts.
The objective of this study is to explore the efficacy of combination PLD-carboplatin
treatment in a larger patient population.
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.
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