Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000071426
Ethics application status
Approved
Date submitted
10/10/2006
Date registered
23/01/2007
Date last updated
29/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
TARCEVA: A randomised, multicentre, phase III study of Erlotinib versus observation in patients with no evidence of disease progression after first line, platinum-based chemotherapy for high-risk Stage I and Stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Scientific title
A randomised, multicentre, phase III study of Erlotinib versus observation in patients
with no evidence of disease progression after first line, platinum-based chemotherapy
for high-risk Stage I and Stage II-IV ovarian epithelial, primary peritoneal, or
fallopian tube cancer to improve progression-free survival.
Secondary ID [1] 332 0
ClinicalTrials.gov: NCT00263822
Universal Trial Number (UTN)
Trial acronym
EORTC TARCEVA 55041
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian epithelial, primary peritoneal, or fallopian tube cancer 1563 0
Condition category
Condition code
Cancer 1664 1664 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1)Treatment Arm: Erlotinib 150 mg orally, administered on a daily basis, up to 2 years
Intervention code [1] 1396 0
Treatment: Drugs
Comparator / control treatment
2)Observation Arm: observation only (standard of care) up to 2 years.
Control group
Active

Outcomes
Primary outcome [1] 2304 0
Progression-free survival
Timepoint [1] 2304 0
Measured as clinically indicated during treatment/observation or follow-up, and at the end of treatment/observation, until recurrence. Abdominal and pelvic Computed tomography (CT) scans and chest X-ray will be performed when clinically indicated, when progression is suspected either clinically or by CA125 monitoring, or at the discretion of the treating physician.
Secondary outcome [1] 4011 0
Overall Survival
Timepoint [1] 4011 0
Measured from randomisation
Secondary outcome [2] 4012 0
Adverse event profile
Timepoint [2] 4012 0
Measured every 3 months during treatment/observation and at follow-up (follow-up at least every 3 months during the first and second year, every 4 months in the 3rd and 4th year, every 6 months the 5th year and thereafter once every year until death)
Secondary outcome [3] 4013 0
Quality of Life (QoL)
Timepoint [3] 4013 0
Measured pre-treatment and every 3 months during treatment/observation.
Secondary outcome [4] 4014 0
Cutaneous toxicity [rash or acne (papulo-pustular rash)]
Timepoint [4] 4014 0
Measured every 3 months during treatment/observation and at follow-up (follow-up at least every 3 months during the first and second year, every 4 months in the 3rd and 4th year, every 6 months the 5th year and thereafter once every year until death.)

Eligibility
Key inclusion criteria
1.Histologically confirmed high-risk International Federation of Gynecology and Obstetrics (FIGO) stage I (grade 3, or aneuploid grade 1 or 2, or clear cell), or stage II-IV ovarian epithelial, primary peritoneal, and fallopian tube cancer.2.Complete response (CR) (clinical and/or pathological, i.e., no evidence of disease [NED] status), partial response (PR), or disease stabilization (SD) after first line therapy3. Eastern Cooperative Oncology Group (ECOG) 0-1. 4. Randomisation within 6 weeks of the end of first line therapy for ovarian cancer (Carboplatin or Cisplatin). 5.Adequate bone marrow, hepatic and renal functions. 6.Written informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Adenocarcinoma of unknown origin.2.Prior or concurrent treatment with any other investigational agent3.Prior therapy targeting the epidermal growth factor receptor (EGFR)4.Prior allergic reaction to any compound chemically related to the study drug5.Previous (within the last 5 years) or concurrent malignancies6.Known history of brain metastases and/or leptomeningeal disease.7.Gastrointestinal tract disease resulting in an inability to take oral medication or requiring parenteral nutrition or affecting absorption. Active peptic ulcer disease.8.Uncontrolled bowel inflammatory disease (e.g., Crohn´s disease or ulcerative colitis).9.Myocardial infarction within the past 6 months.10.Second- or third-degree heart blocks unless pacemaker implanted.11.Significant dermatological disease.12.Inflammatory changes of the surface of the eye.13.Other significant medical condition, neurological or psychiatric disorder.14.Pregnant or lactating women (or potentially fertile women not using adequate contraception).15.Prior radiotherapy.16.Any condition potentially hampering compliance with the study protocol and follow-up schedule.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised web-based randomisation, concealed until interventions are assigned
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation technique
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/09/2005
Actual
15/10/2005
Date of last participant enrolment
Anticipated
Actual
19/02/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
830
Accrual to date
Final
855
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1809 0
Charities/Societies/Foundations
Name [1] 1809 0
European Organisation for Research and Treatment of Cancer
Country [1] 1809 0
Belgium
Primary sponsor type
Other Collaborative groups
Name
European Organisation for Research and Treatment of Cancer
Address
Avenue E. Mounierlaan 83/11
B-1200 Brussels
Country
Belgium
Secondary sponsor category [1] 1629 0
Government body
Name [1] 1629 0
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Address [1] 1629 0
Locked Bag 77
Camperdown NSW 1450
Country [1] 1629 0
Australia
Secondary sponsor category [2] 1630 0
Other Collaborative groups
Name [2] 1630 0
University of Sydney in collaboration with Eastern Organisation for Research and Treatment of Cancer (EORTC)
Address [2] 1630 0
Faculty of Medicine
K25
University of Sydney
NSW 2006
Country [2] 1630 0
Australia
Secondary sponsor category [3] 1631 0
Commercial sector/Industry
Name [3] 1631 0
Roche
Address [3] 1631 0
4-10 Inman Road
Dee Why NSW 2099
Country [3] 1631 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3386 0
University of Sydney
Ethics committee address [1] 3386 0
Ethics committee country [1] 3386 0
Australia
Date submitted for ethics approval [1] 3386 0
Approval date [1] 3386 0
Ethics approval number [1] 3386 0
Ethics committee name [2] 3387 0
Central Ethics Committee
Ethics committee address [2] 3387 0
Ethics committee country [2] 3387 0
New Zealand
Date submitted for ethics approval [2] 3387 0
Approval date [2] 3387 0
Ethics approval number [2] 3387 0
Ethics committee name [3] 3388 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [3] 3388 0
Ethics committee country [3] 3388 0
Australia
Date submitted for ethics approval [3] 3388 0
Approval date [3] 3388 0
22/02/2006
Ethics approval number [3] 3388 0
Ethics committee name [4] 3389 0
Manning Rural Referral Hospital
Ethics committee address [4] 3389 0
Ethics committee country [4] 3389 0
Australia
Date submitted for ethics approval [4] 3389 0
Approval date [4] 3389 0
22/02/2006
Ethics approval number [4] 3389 0
Ethics committee name [5] 3390 0
Tamworth Base Hospital
Ethics committee address [5] 3390 0
Ethics committee country [5] 3390 0
Australia
Date submitted for ethics approval [5] 3390 0
Approval date [5] 3390 0
22/02/2006
Ethics approval number [5] 3390 0
Ethics committee name [6] 3391 0
Royal Brisbane and Women's Hospital
Ethics committee address [6] 3391 0
Ethics committee country [6] 3391 0
Australia
Date submitted for ethics approval [6] 3391 0
Approval date [6] 3391 0
20/02/2006
Ethics approval number [6] 3391 0
Ethics committee name [7] 3392 0
Royal Women's Hospital
Ethics committee address [7] 3392 0
Ethics committee country [7] 3392 0
Australia
Date submitted for ethics approval [7] 3392 0
Approval date [7] 3392 0
17/07/2006
Ethics approval number [7] 3392 0
Ethics committee name [8] 3393 0
Frankston Hospital
Ethics committee address [8] 3393 0
Ethics committee country [8] 3393 0
Australia
Date submitted for ethics approval [8] 3393 0
Approval date [8] 3393 0
02/05/2006
Ethics approval number [8] 3393 0
Ethics committee name [9] 3394 0
Border Medical Oncology
Ethics committee address [9] 3394 0
Ethics committee country [9] 3394 0
Australia
Date submitted for ethics approval [9] 3394 0
Approval date [9] 3394 0
15/02/2006
Ethics approval number [9] 3394 0
Ethics committee name [10] 4720 0
Prince of Wales Hospital
Ethics committee address [10] 4720 0
Ethics committee country [10] 4720 0
Australia
Date submitted for ethics approval [10] 4720 0
Approval date [10] 4720 0
30/05/2006
Ethics approval number [10] 4720 0
Ethics committee name [11] 4721 0
Sir Charles Gairdner Hospital
Ethics committee address [11] 4721 0
Ethics committee country [11] 4721 0
Australia
Date submitted for ethics approval [11] 4721 0
Approval date [11] 4721 0
08/12/2006
Ethics approval number [11] 4721 0
Ethics committee name [12] 4722 0
Christchurch Hospital
Ethics committee address [12] 4722 0
Ethics committee country [12] 4722 0
New Zealand
Date submitted for ethics approval [12] 4722 0
Approval date [12] 4722 0
25/01/2007
Ethics approval number [12] 4722 0
Ethics committee name [13] 4723 0
Palmerston North Hospital
Ethics committee address [13] 4723 0
Ethics committee country [13] 4723 0
Date submitted for ethics approval [13] 4723 0
Approval date [13] 4723 0
25/01/2007
Ethics approval number [13] 4723 0
Ethics committee name [14] 4724 0
Westmead Hospital
Ethics committee address [14] 4724 0
Ethics committee country [14] 4724 0
Australia
Date submitted for ethics approval [14] 4724 0
Approval date [14] 4724 0
25/07/2007
Ethics approval number [14] 4724 0
Ethics committee name [15] 5151 0
Canberra Hospital
Ethics committee address [15] 5151 0
New ethics address. Please modify.
Ethics committee country [15] 5151 0
Australia
Date submitted for ethics approval [15] 5151 0
Approval date [15] 5151 0
22/11/2007
Ethics approval number [15] 5151 0
New ethics HREC. Please modify.

Summary
Brief summary
To determine whether the administration of Erlotinib (maintenance treatment) after first line chemotherapy in patients with ovarian cancer can provide improved outcomes in terms of progression-free survival, compared with the standard approach of observation alone. Roche only will be supplying the drug.
Trial website
Trial related presentations / publications
Vergote I, Jimeno A, Joly F, Katsaros D, Coens C, Despierre E, Marth C, Hall M, Steer C, Colombo N, Lesoin A, Casado A, Reinthaller A, Green J, Buck M, Ray-Coquard I, Ferrero A, Favier L, Reed N, Curé H, Pujade-Lauraine E. Randomised phase III study of erlotinib versus 1 observation in patients with no evidence of disease progression after first line platin-based chemotherapy for ovarian carcinoma. An EORTC-GCG and Gynecological Cancer Intergroup study. Journal of Clinical Oncology. Published ahead of print on December 23, 2013 as 10.1200/JCO.2013.50.5669
Public notes

Contacts
Principal investigator
Name 27623 0
Dr Christopher Steer
Address 27623 0
Border Medical Oncology
Nordsvan Dr and Pearce Dr,
Wodonga VIC 3690
Country 27623 0
Australia
Phone 27623 0
(02) 6051 5300
Fax 27623 0
Email 27623 0
[email protected]
Contact person for public queries
Name 10585 0
Dr Dr Christopher Steer
Address 10585 0
Border Medical Oncology
Nordsvan Drive
Wodonga VIC 3690
Country 10585 0
Australia
Phone 10585 0
+61 2 60553200
Fax 10585 0
+61 2 60567669
Email 10585 0
[email protected]
Contact person for scientific queries
Name 1513 0
Dr Dr Julie Martyn
Address 1513 0
Locked Bag 77
Camperdown NSW 1450
Country 1513 0
Australia
Phone 1513 0
+61 2 95625092
Fax 1513 0
+61 2 95625094
Email 1513 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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