Evaluation of optimal initial treatment duration of bevacizumab in combination with carboplatin and paclitaxel in patients with ovarian cancer.

Phase 1

• Conditions: Following primary cytoreductive surgery, patients with newly diagnosed FIGO stage IIB - IV (all grades and all histological types) epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinomas with indication for a platin/paclitaxel chemotherapy; MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001015-32-DE
• Lead Sponsor: AGO Research GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-17
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

- Written informed consent and patients awareness
and willingness to comply with the study
requirements
- Primary diagnosis is confirmed by specialized
pathology review (Germany only)
- Age = 18 years
- Histologically confirmed, newly diagnosed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma and FIGO stage IIB - IV (all grades and all histological types)
- Patients should have already undergone surgical debulking and no planned surgical debulking prior to disease progression. Patients
with stage III and IV disease in whom initial surgical debulking was not
appropriate or possible are eligible providing other criteria are fulfilled
- Patients able to commence cytotoxic
chemotherapy within 8 weeks of cytoreductive surgery
- ECOG performance status 0-2
- Life expectancy > 3 months
- Adequate bone marrow function, coagulation parameters, liver function, postoperative glomerulare filtration rate (based on the Cockroft-Gault or Jelliffe formula)
- Urine dipstick for proteinuria < 2+. If
urine dipstick is = 2+, 24 hour urine must
demonstrate = 1 g of protein in 24 hours
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

- Non-epithelial origin of the ovary, the fallopian
tube or the peritoneum
- Borderline tumours and FIGO stage IA – IIA
- Planned intraperitoneal cytotoxic chemotherapy
- Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab or anticipation of interval cytoreductive surgery during study treatment
- Uncontrolled hypertension
- Any previous radiotherapy to the abdomen or pelvis
- Previous Cerebro-Vascular Accident, Transient Ischaemic Attack or Sub-Arachnoid Haemorrhage within 6 months prior to randomisation
- Malignancies other than ovarian cancer within 5 years prior to randomisation, except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer and/or non-melanomatous skin cancer, carcinoma in situ of the breast and/or early endometrial carcinoma
- Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless the given single criterion is met
- Non healing wound, active ulcer or bone fracture
- History or evidence of thrombotic or hemorrhagic disorders
- Clinically significant cardiovascular disease, including Myocardial infarction or unstable angina within 6 months of randomisation, NYHA = Grade 2, poorly controlled cardiac arrhythmia despite medication, Grade = 3 peripheral vascular disease
- Current or recent (within 10 days prior to randomisation) chronic use of aspirin > 325 mg/day or use of any other inhibitor of platelet aggregation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare progression-free survival (PFS) (by RECIST v1.1, clinical or symptomatic) of patients randomized to front-line paclitaxel/carboplatin with bevacizumab for 15 months or 30 months.;Secondary Objective: - Objective response rate by RECIST v1.1<br>- Overall survival<br>- Health related Quality of life using EORTC QLQ-C30 and QLQ-OV28 questionnaires<br>- Safety and tolerability<br><br>Further exploratory outcome measures on ancillary studies will include:<br>- Translational Sub Studies<br>- Complementary and Alternative Treatment Qestionnaires;Primary end point(s): Progression-free survival (PFS);Timepoint(s) of evaluation of this end point: At least 697 PFS events have been observed or after data base closure on 30th of November 2020, which ever comes first.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Objective response rate (ORR)<br>- Overall survival (OS)<br>- Quality of life (QoL)<br>- Safety and tolerability<br><br>Further exploratory outcome measures on ancillary studies will include:<br>- Translational Sub Studies<br>- Complementary and Alternative Treatment Questionnaires;Timepoint(s) of evaluation of this end point: OS: 7.5 years appr.