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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00483782




Registration number
NCT00483782
Ethics application status
Date submitted
6/06/2007
Date registered
7/06/2007
Date last updated
12/08/2013

Titles & IDs
Public title
Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Newly Diagnosed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
Scientific title
ICON7 - 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
Secondary ID [1] 0 0
CDR0000548777
Secondary ID [2] 0 0
MREC-ICON7
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fallopian Tube Cancer 0 0
Ovarian Cancer 0 0
Primary Peritoneal Cavity Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - bevacizumab
Treatment: Drugs - carboplatin
Treatment: Drugs - paclitaxel
Other interventions - questionnaire administration
Other interventions - study of socioeconomic and demographic variables
Treatment: Surgery - quality-of-life assessment

Other interventions: bevacizumab


Treatment: Drugs: carboplatin


Treatment: Drugs: paclitaxel


Other interventions: questionnaire administration


Other interventions: study of socioeconomic and demographic variables


Treatment: Surgery: quality-of-life assessment
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Duration of overall survival
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Objective response rate
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Duration of response
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Biological progression-free interval as measured by increasing CA 125 levels
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Safety as measured by NCI CTAE version 3.0
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Quality of life
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Health economics
Timepoint [7] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal
cavity cancer

- Newly diagnosed disease

- Meets 1 of the following staging criteria:

- High-risk stage I or IIA disease (grade 3 disease or clear cell carcinoma only)

- Stage IIB-IV disease (all grades and all histological types)

- Must have undergone initial surgery (e.g., debulking cytoreductive surgery or a biopsy
if the patient has stage IV disease) within the past 6 weeks

- Patients with stage IV disease for which initial surgical debulking was not
appropriate are eligible provided the following criteria are met:

- Stage IV disease diagnosed by histology

- No planned surgery prior to disease progression, including interval
debulking surgery

- Patients with prior early-stage ovarian epithelial or fallopian tube carcinoma treated
with surgery alone are eligible at the time of diagnosis of abdominopelvic recurrence
provided no further interval cytoreductive therapy is planned prior to disease
progression

- Synchronous primary endometrial carcinoma or a past history of primary endometrial
carcinoma allowed provided the following criteria are met:

- Disease = stage IB

- No more than superficial myometrial invasion

- No lymphovascular invasion

- Not poorly differentiated (i.e., no grade 3, papillary serous, or clear cell
disease)

- Measurable or nonmeasurable disease

- No ovarian nonepithelial cancer, including malignant mixed Müllerian tumors

- No borderline tumors (e.g., tumors of low malignant potential)

- No history or clinical suspicion of brain metastases or spinal cord compression

- CT scan or MRI of the brain is mandatory (within 4 weeks prior to randomization)
in case of suspected brain metastases

- Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of
suspected spinal cord compression

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy > 12 weeks

- ANC = 1,500/mm^3

- Platelet count = 100,000/mm^3

- Hemoglobin = 9 g/dL (can be post-transfusion)

- INR = 1.5

- APTT = 1.5 times upper limit of normal (ULN)

- Bilirubin = 1.5 times ULN

- ALT and AST = 2.5 times ULN

- Creatinine = 2.0 mg/dL

- Proteinuria = 1+ by urine dipstick OR = 1 g by 24-hour urine collection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for = 6 weeks after
completion of study therapy

- No significant traumatic injury within the past 4 weeks

- No cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage
within the past 6 months

- No other malignancies within the past 5 years except for adequately treated carcinoma
in situ of the cervix, and/or basal cell skin cancer, and/or early endometrial
carcinoma

- No pre-existing sensory or motor neuropathy = grade 2

- No history or evidence of CNS disease (e.g., uncontrolled seizures) by neurological
examination unless adequately treated with standard medical therapy

- No history or evidence of thrombotic or hemorrhagic disorders

- No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg despite
antihypertensive therapy)

- No known hypersensitivity to bevacizumab and its excipients, chemotherapy, or
Cremophor EL

- No nonhealing wound, ulcer, or bone fracture

- Patients with granulating incisions healing by secondary intention with no
evidence of facial dehiscence or infection are eligible but require three weekly
wound examinations

- No clinically significant cardiovascular disease, including any of the following:

- Myocardial infarction or unstable angina within the past 6 months

- New York Heart Association class II-IV congestive heart failure

- Poorly controlled cardiac arrhythmia despite medication

- Rate-controlled atrial fibrillation allowed

- Peripheral vascular disease = grade 3 (i.e., symptomatic and interfering with
activities of daily living requiring repair or revision)

- No evidence of other disease or condition, metabolic dysfunction, physical examination
findings, or laboratory findings that would contraindicate the use of an
investigational drug or put the patient at high-risk for treatment-related
complications

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 4 weeks since other prior surgery or open biopsy

- No prior systemic therapy for ovarian cancer (e.g., chemotherapy, monoclonal antibody
therapy, tyrosine kinase inhibitor therapy, or hormonal therapy)

- Prior adjuvant chemotherapy allowed for other malignancies (e.g., breast or colorectal
carcinoma) if malignancy was diagnosed over 5 years ago with no evidence of subsequent
recurrence

- No prior mouse CA 125 antibody

- No prior radiotherapy to the abdomen or pelvis

- More than 10 days since prior and no concurrent chronic use of acetylsalicylic acid (>
325 mg/day)

- Low-dose (< 325 mg/day) acetylsalicylic acid allowed

- More than 10 days since prior and no concurrent full-dose oral or parenteral
anticoagulants or thrombolytic agents for therapeutic purposes

- Use of therapy for line patency allowed provided INR < 1.5

- More than 30 days since prior and no other concurrent investigational agent or
participation in another clinical trial

- No other concurrent systemic antitumor agents

- No concurrent surgery

- No concurrent maintenance chemotherapy or intraperitoneal chemotherapy (including
cytotoxic chemotherapy)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1520
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Cancer Therapy Centre at Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [4] 0 0
Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
Recruitment hospital [5] 0 0
Newcastle Mater Misericordiae Hospital - Waratah
Recruitment hospital [6] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Wentworthville
Recruitment hospital [7] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [8] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [9] 0 0
Royal Adelaide Hospital Cancer Centre - Adelaide
Recruitment hospital [10] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [11] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [12] 0 0
Royal Women's Hospital - Carlton
Recruitment hospital [13] 0 0
Mercy Hospital for Women - East Melbourne
Recruitment hospital [14] 0 0
Frankston Hospital - Frankston
Recruitment hospital [15] 0 0
Murray Valley Private Hospital and Cancer Treatment Centre - Wodonga
Recruitment hospital [16] 0 0
Sir Charles Gairdner Hospital - Perth - Perth
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2065 - St. Leonards
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
2145 - Wentworthville
Recruitment postcode(s) [7] 0 0
4029 - Brisbane
Recruitment postcode(s) [8] 0 0
4101 - South Brisbane
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
7000 - Hobart
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3053 - Carlton
Recruitment postcode(s) [13] 0 0
3002 - East Melbourne
Recruitment postcode(s) [14] 0 0
3199 - Frankston
Recruitment postcode(s) [15] 0 0
3690 - Wodonga
Recruitment postcode(s) [16] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Angers
Country [2] 0 0
France
State/province [2] 0 0
Avignon
Country [3] 0 0
France
State/province [3] 0 0
Bordeaux
Country [4] 0 0
France
State/province [4] 0 0
Caen
Country [5] 0 0
France
State/province [5] 0 0
Clermont-Ferrand
Country [6] 0 0
France
State/province [6] 0 0
Colmar
Country [7] 0 0
France
State/province [7] 0 0
Grenoble
Country [8] 0 0
France
State/province [8] 0 0
Le Chesnay
Country [9] 0 0
France
State/province [9] 0 0
Le Mans
Country [10] 0 0
France
State/province [10] 0 0
Lyon
Country [11] 0 0
France
State/province [11] 0 0
Montpellier
Country [12] 0 0
France
State/province [12] 0 0
Nancy
Country [13] 0 0
France
State/province [13] 0 0
Nantes-Saint Herblain
Country [14] 0 0
France
State/province [14] 0 0
Nantes
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
France
State/province [16] 0 0
Pierre Benite
Country [17] 0 0
France
State/province [17] 0 0
Rouen
Country [18] 0 0
France
State/province [18] 0 0
Saint Brieuc
Country [19] 0 0
France
State/province [19] 0 0
Saint Cloud
Country [20] 0 0
France
State/province [20] 0 0
Strasbourg
Country [21] 0 0
France
State/province [21] 0 0
Tours
Country [22] 0 0
France
State/province [22] 0 0
Vandoeuvre-les-Nancy
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Bremen
Country [25] 0 0
Germany
State/province [25] 0 0
Chemnitz
Country [26] 0 0
Germany
State/province [26] 0 0
Dresden
Country [27] 0 0
Germany
State/province [27] 0 0
Ebersberg
Country [28] 0 0
Germany
State/province [28] 0 0
Essen
Country [29] 0 0
Germany
State/province [29] 0 0
Esslingen
Country [30] 0 0
Germany
State/province [30] 0 0
Frankfurt
Country [31] 0 0
Germany
State/province [31] 0 0
Freiburg
Country [32] 0 0
Germany
State/province [32] 0 0
Georgsmarienhuette
Country [33] 0 0
Germany
State/province [33] 0 0
Greifswald
Country [34] 0 0
Germany
State/province [34] 0 0
Halle
Country [35] 0 0
Germany
State/province [35] 0 0
Hannover
Country [36] 0 0
Germany
State/province [36] 0 0
Karlsruhe
Country [37] 0 0
Germany
State/province [37] 0 0
Kassel
Country [38] 0 0
Germany
State/province [38] 0 0
Kiel
Country [39] 0 0
Germany
State/province [39] 0 0
Lahr
Country [40] 0 0
Germany
State/province [40] 0 0
Leonberg
Country [41] 0 0
Germany
State/province [41] 0 0
Lich
Country [42] 0 0
Germany
State/province [42] 0 0
Limburg
Country [43] 0 0
Germany
State/province [43] 0 0
Luebeck
Country [44] 0 0
Germany
State/province [44] 0 0
Lueneburg
Country [45] 0 0
Germany
State/province [45] 0 0
Magdeburg
Country [46] 0 0
Germany
State/province [46] 0 0
Mainz
Country [47] 0 0
Germany
State/province [47] 0 0
Marburg
Country [48] 0 0
Germany
State/province [48] 0 0
Minden
Country [49] 0 0
Germany
State/province [49] 0 0
Munich
Country [50] 0 0
Germany
State/province [50] 0 0
Neunkirchen
Country [51] 0 0
Germany
State/province [51] 0 0
Neuss
Country [52] 0 0
Germany
State/province [52] 0 0
Offenbach
Country [53] 0 0
Germany
State/province [53] 0 0
Paderborn
Country [54] 0 0
Germany
State/province [54] 0 0
Quedlinburg
Country [55] 0 0
Germany
State/province [55] 0 0
Ravensburg
Country [56] 0 0
Germany
State/province [56] 0 0
Siegen
Country [57] 0 0
Germany
State/province [57] 0 0
Sigmaringen
Country [58] 0 0
Germany
State/province [58] 0 0
Stuttgart
Country [59] 0 0
Germany
State/province [59] 0 0
Ulm
Country [60] 0 0
Germany
State/province [60] 0 0
Wiesbaden
Country [61] 0 0
Germany
State/province [61] 0 0
Witten
Country [62] 0 0
Germany
State/province [62] 0 0
Wolfsburg
Country [63] 0 0
Germany
State/province [63] 0 0
Wuppertal
Country [64] 0 0
Norway
State/province [64] 0 0
Oslo
Country [65] 0 0
United Kingdom
State/province [65] 0 0
England
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Northern Ireland
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Scotland
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Other
Name
Medical Research Council
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different
ways to stop the growth of tumor cells, either by killing the cells or stopping them from
dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving
carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and
paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer,
or primary peritoneal cavity cancer.

PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab
to see how well they work compared with carboplatin and paclitaxel alone in treating patients
with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal
cavity cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00483782
Trial related presentations / publications
Dhillon S. Bevacizumab combination therapy: for the first-line treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Drugs. 2012 May 7;72(7):917-30. doi: 10.2165/11208940-000000000-00000.
Public notes

Contacts
Principal investigator
Name 0 0
Tim J. Perren, MD
Address 0 0
Leeds Cancer Centre at St. James's University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00483782