A randomised, two-arm, multi-centre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer

A randomised, two-arm, multi-centre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer to assess progression-free survival benefits

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000188437

Acronym

ICON 7

Enrollment

1520

Registered

2007-03-30

Start date

2006-12-18

Completion date

Unknown

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the ICON 7 study is to evaluate the safety and efficacy of adding bevacizumab, a humanised monoclonal antibody against Vascular Endothelial Growth Factor (VEGF), to standard chemotherapy with carboplatin and paclitaxel for patients with ovarian cancer.

Interventions

Research Arm: Carboplatin (Intravenously, AUC 6) plus paclitaxel (Intravenously, 175mg/m2) on day 1 every 3 weeks (one cycle) until disease progression or for a maximum of 6 cycles, with bevacizumab (intravenously, 7.5mg/kg) on day 1 every 3 weeks (one cycle) until disease progression or for a maximum of 18 cycles

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Written informed consent and able to comply with the protocol2. Histologically confirmed:a. High risk International Federation of Gynecology and Obstetrics (FIGO) stage I and II a, with grade 3 or clear cell histology, epithelial ovarian cancerb. FIGO stage IIb–IV (all grades, all histological types) epithelial ovarian cancerc. Fallopian tube or primary peritoneal cancer3. Patients fit enough to receive protocol treatment4. Urine dipstick for proteinuria <2+ (if urine dipstick is > or = 2+, 24 hour urine must demonstrate < or = 1 g of protein).

Exclusion criteria

1. 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 treatment2. 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 cancer3. Uncontrolled hypertension4. Current or recent (within 10 days of first dose of study treatment) use of aspirin >325 mg/day5. 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).

Outcome results