Global study to assess the addition of bevacizumab to carboplatin and paclitaxel as front-line treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. - ROSiA
- Conditions
- Patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma who havereceived no prior post-surgical therapy for ovarian cancerMedDRA version: 9.1Level: LLTClassification code 10033128MedDRA version: 9.1Level: LLTClassification code 10052204MedDRA version: 9.1Level: LLTClassification code 10016180
- Registration Number
- EUCTR2010-019525-34-IT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1000
1.Written, informed consent obtained prior to any study-specific procedures. 2.Female patients = 18 years. 3.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2. 4.Life expectancy = 3 months. 5.Able to comply with the protocol. 6.Histologically confirmed and documented high risk International Federation of Gynecologic Oncology (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 Or Histologically confirmed and documented clear cell carcinoma regardless of the FIGO stage (clear cell carcinoma is 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. If a patient has had two operations, for example an initial operation to remove what was thought to be a benign cyst and then a second operation to formally stage and maximally debulk the ovarian tumor, then the second operation date should be documented as the date of surgery; the first systemic treatment must start within eight weeks of this date. The date of diagnosis, however, should be recorded as the date of the initial operation where ovarian cancer was diagnosed. 7.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. There must be no planned surgical debulking prior to disease progression. 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 8.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. In such patients bevacizumab is started in addition to the post-surgical chemotherapy cycles.
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
Cancer-related 1.Patients with: •non-epithelial ovarian cancer •ovarian tumors with low malignant potential (i.e. borderline tumors) •synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met: -stage =Ia -no more than superficial myometrial invasion -no lymphovascular invasion -not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma). 2.Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure Prior, current or planned treatment 3.Previous systemic therapy for ovarian cancer (i.e. chemo-, immuno-, hormonal, monoclonal antibody or tyrosine kinase inhibitor therapy). Prior neo-adjuvant chemotherapy is allowed. 4.Previous exposure to mouse CA-125 antibody. 5.Current or recent treatment (within the 28-day period prior to Day 1, Cycle 1) with another investigational drug or previous participation in this study. 6.Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (>325 mg/day). 7.Planned intraperitoneal cytotoxic chemotherapy. 8.Radiotherapy within 28 days of Day 1, Cycle 1. Patients may be given palliative radiotherapy to peripheral sites (e.g. bone metastasis) during this 28 day period but they must have recovered from any acute effects. Prior radiotherapy to any portion of the abdominal cavity or pelvis is not permitted. 9.Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of bevacizumab. or anticipation of the need for major surgery during the course of the study treatment (planned elective surgery). 10.Minor surgical procedures within 2 days prior to Day 1, Cycle 1 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations). Laboratory 11.Inadequate bone marrow function: •absolute neutrophil count < 1.5 x 109/L •platelet count < 100 x 109/L or •hemoglobin (Hb) < 9 g/dL. 12.Inadequate liver function: •serum (total) bilirubin > 1.5 x Upper limit of normal (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). 13.Inadequate renal function: •Serum creatinine >2.0 mg/dl (> 177 ?mol/L) •Urine dipstick for proteinuria should be < 2+. Patients with = ?2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr. 14.Patients not receiving anticoagulant medication who have an international normalized ratio (INR) > 1.5 and an activated partial thromboplastin time (aPTT) > 1.5 x upper limit of normal (ULN) within 7 days prior to Day 1, Cycle 1. *The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of Day 1, Cycle 1. Prior or concomitant conditions or procedures 15.History of myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 6 months prior to Day 1, Cycle 1. 16.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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the safety profile of bevacizumab when added to carboplatin and paclitaxel chemotherapy as front-line treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma.;Primary end point(s): safety endpoint: - The primary variable is the incidence rate of adverse events and rates for selected events with incidences less than 1% - The rate of adverse events is defined as the proportion of patients from the safety population that experienced at least one, or a specific AE.;Secondary Objective: To assess the efficacy of bevacizumab as measured by: - progression-free survival - overall response rate: - by RECIST and 50% CA-125 response criteria (responders”) - by RECIST only (RECIST responders”) - by 50% CA-125 response criteria only (CA-125 responders”) - duration of response - overall survival - biological progression-free interval
- Secondary Outcome Measures
Name Time Method