Lung CancerPhase 3TOPICALNCT00275132
Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Phase 3 study testing erlotinib hydrochloride in people with Lung Cancer, run by University College, London at 1 site in United Kingdom.
Trial summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- erlotinib hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 670 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2005to Apr 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Advanced disease (stage IIIB or IV)
- Diagnosis within 62 days prior to randomization
- Not suitable for first-line chemotherapy, as defined by the following criteria*:
- ECOG performance status 2-3
- ECOG performance status 0-1 AND creatinine clearance < 60 mL/min
- NOTE: *These criteria do not imply that all such patients are unsuitable for chemotherapy; patients are considered unsuitable on a case by case basis
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
- Estimated life expectancy of at least 8 weeks
- Able to take oral medication
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No severe uncontrolled infection
- No unstable angina
- No myocardial infarction within the past month
- No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
- No acute renal failure
- Bilirubin < 2 times upper limit of normal (ULN)
- Transaminases < 2 times ULN (5 times ULN if liver metastases are present)
- Creatinine < 5 times ULN
- No evidence of other significant laboratory finding or uncontrolled medical illness that would interfere with study treatment or results comparison or render the patient at high risk from treatment complications
- No other prior or current malignant disease likely to interfere with study treatment or comparisons
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No prior biological anticancer therapy (e.g., gefitinib, thalidomide, or cetuximab)
- No prior palliative radiotherapy
- Prior palliative radiotherapy to bone metastases allowed within the past 2 weeks
- No concurrent cyclooxygenase-2 inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare survival of patients with stage IIIB or IV non-small cell lung cancer that is not suitable for first-line chemotherapy treated with erlotinib vs placebo.
Secondary
- Compare progression-free survival and response rate.
- Compare toxicity.
- Compare the quality of life.
- Compare cost-effectiveness.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral erlotinib once daily for up to 24 months.
- Arm II: Patients receive oral placebo once daily for up to 24 months. Quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for survival.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 664 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- erlotinib hydrochloride, Matched placebo
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinib hydrochlorideDrug
Also called OSI-774, Tarceva
Tarceva (OSI-774, erlotinib) PO 150 mg daily
Matched placeboDrug
Matched placebo PO daily
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Experimental | Tarceva (OSI-774, erlotinib) PO 150mg daily Receives: Drug: erlotinib hydrochloride |
| Matched placebo | Placebo comparator | Matched placebo PO daily Receives: Drug: Matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: between date of randomisation and date of death from any cause
Secondary outcomes (4)
Progression free survival
Measured: from the date of randomisation to the date of first clinical evidence of progressive disease, or death.
Adverse events/Toxicity
Measured: during and for 28 days following Tarceva/placebo treatment
Quality of life
QL will be measured using the patient-completed EORTC-QLQ C30 and lung cancer module (LC 14). The primary QL outcome measures will be changes in overall QL and the five most commonly reported lung cancer symptoms (fatigue, breathlessness, cough, emotional functioning and pain).
Measured: between randomisation and 8 weeks.
Cost-effectiveness
Effectiveness will be estimated in terms of quality-adjusted life years. Mean survival will be calculated on the basis of observed mortality (i.e. a within-trial estimate) and by extrapolating the survival curves if some patients remain alive at the end of the trial.
Measured: from date of randomisation to death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startApr 2005
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Siow M Lee, MD, PhD, FRCP, Study chair, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275132
- Sponsor's protocol ID
- CDR0000457755
- Other IDs
- LLCG-TOPICAL, EU-20313, ISRCTN, Cancer Research UK (CTAAC), Roche AG Pharma, UCL Trial Sponsor reference, EudraCT number
- Acronym
- TOPICAL
- Status last verified
- Dec 2011
- First submitted
- 10 Jan 2006
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy
- ClinicalTrials.gov ID
- NCT00275132
- Acronym / sponsor ID
- TOPICAL / CDR0000457755
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK, Roche Pharma AG
- Study start
- Apr 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 11 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Compare survival of patients with stage IIIB or IV non-small cell lung cancer that is not suitable for first-line chemotherapy treated with erlotinib vs placebo.
Secondary
- Compare progression-free survival and response rate.
- Compare toxicity.
- Compare the quality of life.
- Compare cost-effectiveness.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral erlotinib once daily for up to 24 months.
- Arm II: Patients receive oral placebo once daily for up to 24 months. Quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for survival.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 664 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib | Experimental | Drug: erlotinib hydrochlorideTarceva (OSI-774, erlotinib) PO 150mg daily |
| Matched placebo | Placebo comparator | Drug: Matched placeboMatched placebo PO daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erlotinib hydrochlorideAlso: OSI-774, TarcevaTarceva (OSI-774, erlotinib) PO 150 mg daily | Drug | Erlotinib |
| Matched placeboMatched placebo PO daily | Drug | Matched placebo |
Primary outcome
Overall survival
Time frame: between date of randomisation and date of death from any cause
4 secondary outcomes
Progression free survival
Time frame: from the date of randomisation to the date of first clinical evidence of progressive disease, or death.
Adverse events/Toxicity
Time frame: during and for 28 days following Tarceva/placebo treatment
Quality of life
Time frame: between randomisation and 8 weeks.
Cost-effectiveness
Time frame: from date of randomisation to death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siow M Lee, MD, PhD, FRCP study chair
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing erlotinib hydrochloride in people with Lung Cancer, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: between date of randomisation and date of death from any cause). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.