Platinum Sensitive Recurrent Ovarian Epithelial Cancer
Conditions
Interventions
Product Name: AS1404 (DMXAA)
Pharmaceutical Form: Solution for injection
Current Sponsor code: AS1404
Other descriptive name: DMXAA
Conc
Sponsors
Antisoma Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i) Age equal to, or greater than 18 years. ii) ECOG performance status 0-2. iii) Life expectancy greater than or equal to 3 months. iv) Have first recurrent ovarian epithelial cancer including recurrent primary peritoneal serous carcinoma, confirmed by imaging, with a progression-free interval of greater than 6 months after response to platinum-based chemotherapy. v) At least six months since prior chemotherapy or radiotherapy (except palliative radiation where the target lesion is not in the field of the radiation) and recovery from any related toxicities. vi) Have histologically confirmed ovarian epithelial cancer including primary peritoneal serous carcinoma, with at least one unidimensionally measurable lesion according to the RECIST criteria (Measurable disease greater than or equal to 20 mm (or greater than or equal to 10 mm on spiral CT scan)). Haematological and biochemical indices at screening within the following ranges: vii) An absolute neutrophil count of =2.0 x 10E9/l, viii) A platelet count of =100 x 10E9/l, ix) A haemoglobin level of > 10 g/dl, x) Adequate hepatic and renal function as defined by serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i) Patients who have undergone or those who have had major surgery within the past 4 weeks, chemotherapy or radiation therapy (except palliative). ii) Who progressed during prior platinum based chemotherapy and or have a known history of hypersensitivity to paclitaxel, carboplatin or any of their excipients. iii) Previous exposure to AS1404 or other vascular targeting agents. iv) Received blood transfusions or growth factors to aid haematological recovery within two weeks of scheduled baseline visit. v) Concurrent severe and/or uncontrolled co-morbid medical condition within 2 weeks of screening. vi) Clinically significant cardiac arrhythmias and known QTc prolongation. vii) Evidence of severe or uncontrolled systemic disease that in the opinion of the Investigator might interfere with the patient's participation in the study, including but limited to unstable or uncompensated respiratory disorder, cardiac failure, hepatic, renal or metabolic disorders including uncontrolled diabetes mellitus. viii) A history of alcoholism, drug addiction; or any psychiatric condition which in the opinion of the Investigator would impair the patient’s ability to comply with study procedures. ix) Pregnant or lactating women. Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception, in the opinion of the Investigator (post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential). Treatment with the following medications within two weeks of AS1404 administration or the expected need for such treatments during the study period: x) Medications known to modulate serotonin including but not limited to: Antidepressants (including but not limited to monoamine oxidase inhibitors (MAOIs), tetracyclics, tricyclics, SSRIs) Pethidine Amphetamines Tryptophan Dextromethorphan Tramadol xi) Medications known to affect the QT interval including but not limited to: Antiarrhythmics: Quinidine, Disopyramide, Procainamide (NAPA), Sotalol, Ibutilide, Amiodarone Calcium-channel blockers: Bepridil, Lidoflazine CNS-active agents: Thioridazine, Tricyclic antidepressants, Pimozide Antibiotics: Erythromycin, Pentamidine, cotrimoxazole Antihistamines: Terfenadine, Astemizole Miscellaneous: Terodiline, liquid protein diets, ketanserin organophosphorus insecticides, Cisapride, Probucol xii) Concurrent or previous malignancy of a different tumour type except for adequately treated non-melanoma skin cancer or CIN. xiii) Clinical or radiological evidence of CNS metastases. xiv) Symptomatic peripheral neuropathy =NCI-CTC grade II. xv) Unresolved bowel obstruction. xvi) Symptomatic brain metastases. xvii) Evidence of any other significant clinical disorder or laboratory finding that in the opinion of the Investigator compromises the patient safety during study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall aim of this study is to determine whether AS1404 will increase efficacy of carboplatin and paclitaxel combination in treating patients with platinum-sensitive recurrent ovarian epithelial cancer.;Secondary Objective: To determine the safety and tolerability of the combination.; Primary end point(s): The tumour response rate and time to progression. The duration of response and stable disease· One year and median survival. Safety and tolerability of the combination. | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed