Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00263822




Registration number
NCT00263822
Ethics application status
Date submitted
7/12/2005
Date registered
9/12/2005
Date last updated
27/08/2013

Titles & IDs
Public title
Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer
Scientific title
A Randomized, Multicenter, Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line, Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Secondary ID [1] 0 0
EORTC-55041
Secondary ID [2] 0 0
EORTC-55041
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)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - erlotinib hydrochloride

Treatment: Drugs: erlotinib hydrochloride
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Adverse event profile
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Quality of life
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Cutaneous toxicity (rash or acne [papulo-pustular rash])
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube
cancer meeting 1 of the following criteria:

- High-risk stage I disease, as defined by grade 3, aneuploid grade 1 or 2, or
clear cell disease

- Stage II, III, or IV disease

- Completed first-line therapy within the past 6 weeks

- Received a platinum derivative (carboplatin or cisplatin) alone or in combination
with other agents for 6-9 courses

- Must have achieved complete response/no evidence of disease, partial response, or
stabilization of disease after therapy

- No adenocarcinoma of unknown origin

- No known brain metastases or leptomeningeal disease

PATIENT CHARACTERISTICS:

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Platelet count = 100,000/mm^3

- WBC = 2,000/mm^3

Hepatic

- AST and ALT = 2.5 times upper limit of normal (ULN) (= 5 times ULN in patients with
known liver metastases)

- Bilirubin = 1.5 times ULN

- Alkaline phosphatase = 5 times ULN except in patients with known bone metastases

- PT and PTT = 1.5 times ULN

Renal

- Creatinine = 2 times ULN

Cardiovascular

- No myocardial infarction within past 6 months

- No second- or third-degree heart block without pacemaker

Gastrointestinal

- No active peptic ulcer disease

- No gastrointestinal tract disease that would interfere with ability to take oral
medications, affect absorption, or require parenteral nutrition

- No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative
colitis)

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No significant dermatologic disease

- No inflammatory changes to the surface of the eye

- No history of allergic reaction to compounds of similar chemical composition as
erlotinib

- No other significant medical condition or neurologic or psychiatric disorder

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or cone-biopsied carcinoma in situ of the cervix

- No psychiatric illness or familial, geographic, or social situation that would
preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior therapy targeting epidermal growth factor receptor

- No concurrent immunotherapy

Chemotherapy

- See Disease Characteristics

- See Surgery

- No concurrent chemotherapy

Endocrine therapy

- No concurrent hormonal therapy

Radiotherapy

- No prior radiotherapy unless completed more than 5 years ago AND outside the
abdomen/pelvis

Surgery

- Interval debulking surgery after 3 courses of chemotherapy and second-look surgery at
the end of chemotherapy allowed as per study EORTC-55971/NCIC OV13/Chorus

Other

- No other prior or concurrent investigational agents

- No other concurrent anticancer treatment

- Concurrent participation in study EORTC-55971/NCIC-OV13/Chorus allowed
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
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
835
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [2] 0 0
Tamworth Base Hospital - Tamworth
Recruitment hospital [3] 0 0
Manning Base Hospital - Taree
Recruitment hospital [4] 0 0
Newcastle Mater Misericordiae Hospital - Waratah
Recruitment hospital [5] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [6] 0 0
Royal Women's Hospital - Carlton
Recruitment hospital [7] 0 0
Frankston Hospital - Frankston
Recruitment hospital [8] 0 0
Murray Valley Private Hospital and Cancer Treatment Centre - Wodonga
Recruitment hospital [9] 0 0
Sir Charles Gairdner Hospital - Nedlands - Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2340 - Tamworth
Recruitment postcode(s) [3] 0 0
2430 - Taree
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
4029 - Brisbane
Recruitment postcode(s) [6] 0 0
3053 - Carlton
Recruitment postcode(s) [7] 0 0
3199 - Frankston
Recruitment postcode(s) [8] 0 0
3690 - Wodonga
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Klagenfurt
Country [2] 0 0
Austria
State/province [2] 0 0
Kufstein
Country [3] 0 0
France
State/province [3] 0 0
Amilly
Country [4] 0 0
France
State/province [4] 0 0
Aulnay Sous Bois
Country [5] 0 0
France
State/province [5] 0 0
Besancon
Country [6] 0 0
France
State/province [6] 0 0
Bordeaux
Country [7] 0 0
France
State/province [7] 0 0
Boucher
Country [8] 0 0
France
State/province [8] 0 0
Caen
Country [9] 0 0
France
State/province [9] 0 0
Chambery
Country [10] 0 0
France
State/province [10] 0 0
Clermont-Ferrand
Country [11] 0 0
France
State/province [11] 0 0
Colmar
Country [12] 0 0
France
State/province [12] 0 0
Dax
Country [13] 0 0
France
State/province [13] 0 0
Evreux
Country [14] 0 0
France
State/province [14] 0 0
Gap
Country [15] 0 0
France
State/province [15] 0 0
La Roche Sur Yon
Country [16] 0 0
France
State/province [16] 0 0
Le Mans
Country [17] 0 0
France
State/province [17] 0 0
Lorient
Country [18] 0 0
France
State/province [18] 0 0
Lyon
Country [19] 0 0
France
State/province [19] 0 0
Marseille
Country [20] 0 0
France
State/province [20] 0 0
Mont-de-Marsan
Country [21] 0 0
France
State/province [21] 0 0
Montbeliard
Country [22] 0 0
France
State/province [22] 0 0
Montlucon
Country [23] 0 0
France
State/province [23] 0 0
Montpellier
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Perigueux
Country [26] 0 0
France
State/province [26] 0 0
Pierre Benite
Country [27] 0 0
France
State/province [27] 0 0
Poitiers
Country [28] 0 0
France
State/province [28] 0 0
Reims
Country [29] 0 0
France
State/province [29] 0 0
Rennes
Country [30] 0 0
France
State/province [30] 0 0
Saint Brieuc
Country [31] 0 0
France
State/province [31] 0 0
Strasbourg
Country [32] 0 0
France
State/province [32] 0 0
Tours
Country [33] 0 0
France
State/province [33] 0 0
Valence
Country [34] 0 0
France
State/province [34] 0 0
Vandoeuvre-les-Nancy
Country [35] 0 0
Italy
State/province [35] 0 0
Aviano
Country [36] 0 0
Italy
State/province [36] 0 0
Como
Country [37] 0 0
Italy
State/province [37] 0 0
Latina
Country [38] 0 0
Italy
State/province [38] 0 0
Milan
Country [39] 0 0
Italy
State/province [39] 0 0
Monza
Country [40] 0 0
Italy
State/province [40] 0 0
Turin
Country [41] 0 0
Italy
State/province [41] 0 0
Varese
Country [42] 0 0
Netherlands
State/province [42] 0 0
Amsterdam
Country [43] 0 0
Netherlands
State/province [43] 0 0
Groningen
Country [44] 0 0
Netherlands
State/province [44] 0 0
Leiden
Country [45] 0 0
Netherlands
State/province [45] 0 0
Nijmegen
Country [46] 0 0
Netherlands
State/province [46] 0 0
Rotterdam
Country [47] 0 0
Portugal
State/province [47] 0 0
Coimbra
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Spain
State/province [50] 0 0
Oviedo
Country [51] 0 0
Spain
State/province [51] 0 0
Valencia
Country [52] 0 0
United Kingdom
State/province [52] 0 0
England
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Scotland
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Sometimes after treatment, the tumor may not need additional
treatment until it progresses. In this case, observation may be sufficient. It is not yet
known whether erlotinib is more effective than observation after first-line chemotherapy in
treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works
compared to observation in treating patients who have undergone first-line chemotherapy for
ovarian cancer, peritoneal cancer, or fallopian tube cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00263822
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Antonio Jimeno
Address 0 0
Hospital Universitario 12 de Octubre
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/NCT00263822