ICON7 - A randomised, two-arm, multicentre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer. - ICON7 GCIG Trial (International Collaborative Ovarian Neoplasm 7)

• Conditions: Following initial surgery (either debulking cytoreductive surgery or a biopsy if the patient has FIGO stage IV disease and there is no planned surgery before disease progression) patients with newly diagnosed FIGO stage I or IIa (Grade 3 or clear cell histology only), or FIGO stage IIb - IV (all grades and all histological types) epithelial ovarian, fallopian tube or primary peritoneal cancer, in whom no further surgery prior to disease progression is planned; MedDRA version: 8.1Level: LLTClassification code 10033128Term: Ovarian cancer

• Registration Number: EUCTR2005-003929-22-FI
• Lead Sponsor: Medical Research Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-20
• Last Update Posted: 28 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1520

Inclusion Criteria

- Age over 18 (as standard treatments not licensed for use in those under 18 years)

- Written informed consent and able to comply with the protocol

- Histologically confirmed high risk FIGO stage I and II a (grade 3 or clear cell histology), or FIGO stage IIb – IV (all grades, all histological types) epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer

- Patients should have already undergone cytoreductive surgery and not be planned for any further surgical debulking prior to disease progression. Patients with stage IV disease in whom surgical debulking was not appropriate are eligible providing other criteria are fulfilled

- Patients able to receive protocol treatment

- ECOG performace status 0-2

- Life expectancy > 12 weeks

- Patients fit enough to begin treatment within 6 weeks of surgery
- Urine dipstick for proteinuria < 2+ (If urine dipstick is > or = 2+, 24 hour urine must demonstrate < or = 1 g of protein)

-Adequate bone marrow, renal and liver function
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 ovarian cancer or borderline tumours

- Planned intraperitoneal therapy

- Surgery (including open biopsy), or radiotherapy within the last 4 weeks prior to first dose of bevacizumab or anticipation of interval cytoreductive surgery during study treatment

- 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 early endometrial carcinoma

- Uncontrolled hypertension

- Previous CVA, TIA or sub arachnoid haemorrhage within 6 months prior to randomisation

- MI or unstable angina within 6 months prior to randomisation

- History of thrombotic or haemmorhagic disorder

- Previous gastrointestinal perforation and/or clinical suspicion of frank or impending bowel obstruction

- Current or recent (within 10 days of first dose of study treatment) use of aspirin > 325 mg/day

- Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes (except for line patency)

Study & Design

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