Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer (TOPICAL)

University College London (UCL)

Status and phase

Completed

Phase 3

Conditions

Lung Cancer

Treatments

Drug: Matched placebo

Drug: erlotinib hydrochloride

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00275132

CDR0000457755

Roche AG Pharma (Other Grant/Funding Number)

ISRCTN (Registry Identifier)

EU-20313

EudraCT number (Other Identifier)

UCL Trial Sponsor reference (Other Identifier)

Cancer Research UK (CTAAC) (Other Grant/Funding Number)

LLCG-TOPICAL

Details and patient eligibility

About

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.

Full 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.

Enrollment

670 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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