Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
|
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 evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00091156 |
|
Recruitment Status :
Terminated
(low accrual)
First Posted : September 8, 2004
Last Update Posted : July 16, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether giving gefitinib after initial chemotherapy is effective in delaying the recurrence of non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared to placebo in delaying tumor recurrence in patients who have undergone initial chemotherapy for stage IIIB or stage IV non-small cell lung cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer | Drug: gefitinib Procedure: adjuvant therapy | Phase 3 |
OBJECTIVES:
Primary
- Compare overall survival of patients with stage IIIB or IV non-small cell lung cancer that did not progress on prior first-line palliative induction chemotherapy when treated with adjuvant gefitinib vs placebo.
Secondary
- Compare progression-free survival of patients treated with these regimens.
- Determine the safety and toxicity of gefitinib in these patients.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to initial disease stage (IIIB vs IV), WHO performance status at the end of prior first-line palliative induction chemotherapy (0-1 vs 2), best patient response to prior first-line palliative induction chemotherapy (objective response vs stable disease), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral gefitinib once daily.
- Arm II: Patients receive oral placebo once daily. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 598 patients (299 per treatment arm) will be accrued for this study within 8.5 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 598 participants |
| Allocation: | Randomized |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Phase III Study of Follow Up With or Without Adjuvant Gefitinib (Iressa™) Following Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer |
| Study Start Date : | May 2004 |
| Actual Primary Completion Date : | July 2008 |
- Overall survival
- Progression-free survival
- Toxicity as assessed by CTC
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria:
-
Stage IIIB
- Pleural fluid and/or supraclavicular nodes allowed provided patient is not eligible for consolidation radiotherapy
- Stage IV disease
-
- No disease progression after 2-6 courses of prior platinum-containing first-line palliative induction chemotherapy
- Brain metastases allowed provided patients are asymptomatic after cranial irradiation completed at least 4 weeks ago
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Pulmonary
-
No history, signs, or symptoms of clinically active interstitial lung disease
- Patients with chronic, stable, asymptomatic radiographic changes are eligible
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- No other malignant disease within the past 5 years except basal cell skin cancer or adequately treated superficial carcinoma of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- Recovered from prior chemotherapy (alopecia allowed)
- No concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Other
- No prior epidermal growth factor receptor inhibitors
-
No concurrent administration of any of the following drugs:
- Phenytoin
- Carbamazepine
- Rifampin
- Phenobarbital
- Hypericum perforatum (St. John's wort)
- No other concurrent anticancer therapy
- No other concurrent experimental drugs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091156
Show 28 study locations
| Study Chair: | Jan P. Van Meerbeeck, MD, PhD | Universitair Ziekenhuis Gent |
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00091156 |
| Other Study ID Numbers: |
EORTC-08021 EORTC-08021 ILCP-01/03 2004-001331-36 ( EudraCT Number ) |
| First Posted: | September 8, 2004 Key Record Dates |
| Last Update Posted: | July 16, 2012 |
| Last Verified: | July 2012 |
|
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Gefitinib Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |