Health Condition 1: null- Ovarian Cancer, fallopian tube carcinoma or primary peritoneal carcinoma
Conditions
Interventions
Intervention1: Bevacizumab: 15 mg/Kg once every 3 weeks for minimum 21 Cycles overall
Control Intervention1: NIL: -
Sponsors
F HoffmannLa Roche Ltd
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Adult female patients with ECOG PS of 0, 1 or 2 and minimum life expectancy 3 months. Histologically confirmed and documented high risk FIGO Stage I/IIa (only if grade 3 / poorly differentiated) or Stage IIb/IV (any grade) epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma Or Histologically confirmed and documented clear cell carcinoma regardless of the FIGO stage (defined as either 50% clear cell elements present or reported as clear cell carcinoma by the local pathologist). Or Histologically confirmed and documented carcinosarcoma. Patients with recurrent ovarian cancer that have been previously treated with surgery alone for their early stage disease are eligible. Patients should have already undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction according to the GCIG Conference Consensus Statement. Patients with stage III and IV disease in whom initial surgical debulking was not appropriate will still be eligible providing -the patient has a histological diagnosis and -debulking surgery prior to disease progression is not foreseen Eligible for carboplatin (or cisplatin) and paclitaxel chemotherapy treatment in accordance with local standards of care following cytoreductive surgery. Patients who have received neo-adjuvant chemotherapy may be included.
Exclusion criteria
Exclusion criteria: Patients with - non-epithelial ovarian cancer or Ovarian tumors with low malignant potential (i.e. borderline tumors) -stage Ia -no more than superficial myometrial invasion -no lymphovascular invasion -not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma). Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure Prior, current or planned treatment Previous systemic therapy for ovarian cancer (i.e. chemo-, immuno-, hormonal, monoclonal antibody or tyrosine kinase inhibitor therapy). Prior neo-adjuvant chemotherapy is allowed. Planned intraperitoneal cytotoxic chemotherapy. Radiotherapy within 28 days of Day 1, Cycle 1. Inadequate bone marrow function: -absolute neutrophil count < 1.5 x 109/L -platelet count < 100 x 109/L or -Hb < 9 g/dL. Inadequate liver function: -serum (total) bilirubin > 1.5 x ULN -AST & ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases) or -alkaline phosphatase > 2.5 x ULN (or > 5 x ULN in case of liver metastases or > 10 x ULN in case of bone metastases). Inadequate renal function: -Serum creatinine >2.0 mg/dl (> 177 µmol/L) -Urine dipstick for proteinuria should be < 2+. History of myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 6 months prior to Day 1, Cycle 1. Uncontrolled hypertension (current systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg) or history of hypertensive crisis or hypertensive encephalopathy. Clinically significant (i.e. active) cardiovascular disease (e.g. NYHA Class II or greater congestive heart failure, aortic aneurysm). History or evidence upon physical/neurological examination of central nervous system (CNS) disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| End of study is defined as the date the last patient completes the 36th cycle of bevacizumab treatment. Patients will be followed (for survival and for progression-free survival) until 30 days after the last treatment cycle with bevacizumab in any patient.Timepoint: 2 year enrolment period starting december 2010. Study completion by 2014 december | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival 2. Overall response rate 3. Duration of Response 4. Overall survival 5. Biological progression-free interval Timepoint: At the End of the study | — |
Countries
Argentina, Austria, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Denmark, Egypt, Estonia, Finland, France, Greece, Hungary, India, Ireland, Israel, Italy, Kuwait, Latvia, Lithuania, Netherlands, Oman, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Uruguay
Contacts
Public ContactDr Amit Qamra
Roche Products (India) Pvt. Ltd.
Outcome results
None listed