None listed
Conditions
Brief summary
This study will evaluate the effect of combining standard chemotherapy with the drug, BNC105P, for the treatment of partially platinum sensitive ovarian cancer. Who is it for? You may be eligible to join this study if you are a female aged 18years or above and have a diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, for which you have undergone first or second line platinum based chemotherapy. Your cancer should not have progressed for at least 4 months following this chemotherapy. Trial details There are two parts to this study. Each participant will be involved in one part only. In part 1 of the study, participants will undergo chemotherapy with carboplatin, gemcitabine, and BNC105P for up to 6 cycles (each cycle is 21 days). Subsequent patients will receive escalating doses of these drugs in order to determine the maximum tolerated dose. Participants will then undergo a further 6 cycles of maintenance therapy with BNC105P only. Participants enrolled in part 2 of this study will be randomly (by chance) allocated to one of two groups. Both groups will undergo standard chemotherapy with Carboplatin and Gemcitabine for 6 cycles (each cycle is 21 days). However, one group will also receive the maximum tolerated dose (determined in part 1 of the study) of BNC105P during these cycles. Both groups will then undergo a maximum of 6 cycles of maintenance therapy with BNC105P. Participants in both parts of the study will be assessed at regular intervals in order to evaluate the safety of treatment, response rate, and quality of life.
Interventions
Phase I: Carboplatin AUC 4 day 1 given IV over 60 minutes, Gemcitabine escalations 800 and 1000 mg/m2 days 1 and 8, given IV over 30 minutes, BNC105P escalations at 8, 12 or 16mg/m2 days 2 and 9, given IV over 10 minutes, all every 21 days, for 6 cycles, followed by single agent maintenance BNC105P for a maximum of 6 additional cycles at 16 mg/m2 on days 2 and 9.
Phase II: Carboplatin AUC 4 day 1 IV over 60 minutes, Gemcitabine 800 or 1000 mg/m2 days 1 and 8 IV over 30 minutes as determined in
Phase I: Carboplatin AUC 4 day 1 given IV over 60 minutes, Gemcitabine escalations 800 and 1000 mg/m2 days 1 and 8, given IV over 30 minutes, BNC105P escalations at 8, 12 or 16mg/m2 days 2 and 9, given IV over 10 minutes, all every 21 days, for 6 cycles, followed by single agent maintenance BNC105P for a maximum of 6 additional cycles at 16 mg/m2 on days 2 and 9. Phase II: Carboplatin AUC 4 day 1 IV over 60 minutes, Gemcitabine 800 or 1000 mg/m2 days 1 and 8 IV over 30 minutes as determined in the Phase I component, given with OR without BNC105P at previously defined MTD on days 2 and 9, all every 21 days for 6 cycles, followed by a maximum of 6 cycles of single agent BNC105P at 16 mg/m2.
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase I only 1. Histologically or cytologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, including all histological subtypes and carcinosarcoma. 2. Progression-free interval > 4 months (as per GCIG definition of progression) after first or second line platinum (cisplatin or carboplatin) based chemotherapy. 3. Performance status of ECOG 0-1. Phase II only 1. Histologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. 2. Progression-free interval between 4 to 9 months after first line chemotherapy or 4 to 12 months after second-line chemotherapy with a platinum (cisplatin or carboplatin) based regimen. 3. Subjects must have progressed (based on GCIG CA125 and/or RECIST criteria) after last platinum based regimen 4. Subjects must be assessable for response based on GCIG CA125 and/or RECIST criteria. 5. Subjects with clinically evident ascites and/or pleural effusions must be assessable by RECIST. 6. If the calculated GFR is 50 - 54 ml/min an isotopic GFR may be performed. If the isotopic GFR is > 55ml/min, the patient will be eligible for the study but the calculated GFR will be used for dose calculation. 7. Performance status of ECOG 0-2 8. Study treatment both planned and able to start within 7 days of randomisation
Exclusion criteria
Phase II only 1. Carcinosarcoma and mucinous carcinoma Phase I and II 1. Non-epithelial ovarian cancer and ovarian tumours of low malignant potential (borderline tumours) 2. More than two prior chemotherapy regimens for ovarian cancer (excluding hormonal therapy or biologic agents). 3. Any prior chemotherapy for other cancers, but >10 years permitted for phase II only, except for high dose chemotherapy/autologous or allogeneic transplantation 4. Chemotherapy within 20 days prior to registration. 5. Hormonal therapy or biologic therapy within 28 days prior to registration 6. Concurrent treatment with any experimental drugs or other anti-cancer therapy. 7. Concurrent treatment with clopidogrel, ticlopidine, persantin and other antiplatelet agents 8. Radiotherapy within 21 days prior to registration, or to greater than 15% of the bone marrow. 9. Persistent toxic effects of previous chemotherapy of greater than grade 1 severity
Outcome results
None listed