liposome-encapsulated doxorubicin citrate and carboplatin in treating patients with advanced or metastatic recurrent endometrial cancer

Conditions: Endometrial Cancer

Summary: rationale: drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well liposome-encapsulated doxorubicin citrate given together with carboplatin works in treating patients with advanced or metastatic recurrent endometrial cancer.

objectives: primary * to assess activity of the combination of liposome-encapsulated doxorubicin citrate and carboplatin in patients with primary advanced or metastatic recurrent carcinoma of the endometrium. secondary * to assess the toxicity and feasibility of this regimen in these patients. * to determine the progression-free survival and overall survival of these patients. outline: this is a multicenter study. patients receive liposome-encapsulated doxorubicin citrate iv over 1 hour followed by carboplatin iv over 30 minutes on day 1. treatment repeats every 21 days for 6-9 courses in the absence of disease progression or unacceptable toxicity. tissue array and immunohistochemistry analysis are conducted on paraffin-embedded tumor blocks of the primarily operated tissue of all patients for different markers (e.g., progesterone-/estrogen receptor, her2-receptor, soluble l1-molecule, topo 2a) to examine tumor characteristics. quality of life is assessed at baseline, during study treatment, at completion of study treatment, and then at 1 year after completion of study treatment. after completion of study therapy, patients are followed up every 3 months for 1 year.

Eligibility criteria:
disease characteristics: * diagnosis of endometrial carcinoma, including any of the following cellular types: * mixed mullerian carcinoma * serous carcinoma * clear cell carcinoma * primary advanced (figo stage iii or stage iv) or metastatic recurrent disease * disease not curable by surgery * measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with x-ray, physical exam, or non-spiral ct scan or ≥ 10 mm with spiral ct scan or mri * no known cerebral metastases patient characteristics: * ecog performance status 0-2 * life expectancy ≥ 12 weeks * platelet count ≥ 100,000/mm\^3 * anc ≥ 1,500/mm\^3 * hemoglobin ≥ 10 g/dl * creatinine ≤ 1.25 times upper limit of normal (uln) * bilirubin ≤ 1.25 times uln * ast/alt \< 3 times uln * glomerular filtration rate ≥ 50 ml/min * lvef ≥ 50% by echo * fertile patients must use effective contraception * no myocardial infarction within the past 6 months * no nyha class ii-iv congestive heart failure * no third degree or complete heart block unless a pacemaker is in place * no other malignancy within the past 5 years * no concomitant medical illness (e.g., uncontrolled infection, uncontrolled angina, or other relevant illness) that makes the prescribed treatments within this study unfeasible * no known hypersensitivity to study drugs * no psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule prior concurrent therapy: * no prior chemotherapy for disease recurrence * at least 12 months since prior adjuvant therapy containing anthracyclines with cumulative doses not exceeding the following: * epirubicin 600 mg/m² * doxorubicin 300 mg/m² * at least 6 months since prior adjuvant therapy containing platinum * at least 4 weeks since completion of radiotherapy involving the whole pelvis * no concurrent radiotherapy or planned radiotherapy after study * no concurrent endocrine, immunological, or other anticancer therapy * no concurrent participation in another investigational drug study

Keywords: endometrial clear cell carcinoma recurrent endometrial carcinoma stage iiia endometrial carcinoma stage iiib endometrial carcinoma stage iiic endometrial carcinoma stage iva endometrial carcinoma stage ivb endometrial carcinoma