Antitumoral activity and safety of AEZS-108 (AN-152), a LHRH agonist linked doxorubicin, in women with LHRH receptor positive gynecological tumors - AEZS-108 in patients with LHRH receptor positive gynecological tumors

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 82

Inclusion Criteria

1) Woman = 18 years of age
2) LHRH receptor positive tumor status: positive receptor status determined by immunohistochemistry from primary tumor
3) Stratum A - ovarian cancer:
• Histologically confirmed epithelial ovarian cancer
• Advanced stage: FIGO III or IV or recurrent disease
• Progression during treatment with a platinum-based regimen or within 6 months after receiving a platinum-based regimen
• Previous treatment with a taxane-containing regimen
• No previous anthracycline-based chemotherapy and not more than 2 previous chemotherapies or cytostatic therapies
• At least one measurable target lesion (RECIST criteria)
OR
CA125 level higher than twice the upper limit of normal range (GCIG criteria)
4) Stratum B - endometrium cancer:
• Histologically confirmed endometrial cancer
• Advanced (FIGO III or IV) or recurrent disease
• No previous anthracycline-based chemotherapy
• Previous endocrine therapy is allowed
• At least one measurable target lesion according to RECIST criteria

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

1) History of allergic reaction to anthracycline or peptide drugs or to protein.
2) Patients with a history of unstable or newly diagnosed angina pectoris, documented history or current serious arrhythmia or CHF or recent myocardial infarction (within 6 months of enrolment).
3) Left ventricular ejection fraction (LVEF) < 60%.
4) Prior radiotherapy to the pericardial area > 35 Gy and more than 50% of bone marrow involved
5) Concomitant use of potentially cardiotoxic medication (e.g. calcium channel entry blockers).
6) Chemo-, immune-, hormone-, or radiotherapy within 4 weeks prior to entry (nitrosoureas or mitomycin C: 6 weeks).
7) Any non-compensated or uncontrolled non-malignant condition, such as active tuberculosis or any other active infection.
8) Any of the following laboratory values:
- thrombocyte count: < 100x109/L;
- absolute neutrophil count (ANC): < 1.5x109/L;
- hemoglobin: < 6.8 mmol/L (< 11 g/100 mL);
- ASAT, ALAT, AP: > 2.5 times upper limit of normal range (ULN): (> 5x ULN if clearly related to liver metastases);
- creatinine, bilirubin: > ULN.
9) Lactating female or female of child-bearing potential not employing adequate contraception.
10) Brain metastasis, leptomeningeal disease.
11) ECOG performance > 2.
12) Life expectancy < 3 months.
13) Neurological or psychiatric disease or drug or alcohol abuse which would interfere with the subjects’ proper completion of the protocol assignment.
14) Use of LHRH agonist or antagonist treatment within 6 months prior to entry.
15) Concomitant or recent (within 8 weeks) treatment with other investigational drug; or prior treatment with AEZS-108 (at any time)
16) Ovarian cancer patients without initial measurable disease must
not have received mouse antibodies (unless the CA 125 assay used has been shown not to be influenced by human antimouse antibodies (HAMA)) AND
17) not have had surgical or medical manipulation of their peritoneal or pleural cavity within 4 weeks preceding their screening for initial CA 125