First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00344773
• Collaborator: (none)
• Enrollment: 46
• Locations: 2
• Arm: 1
• Duration (Months): 21
• Patients Per Site: 23
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Cancer	Drug: Gefitinib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Multi-centre Study to Evaluate Efficacy and Safety of Gefitinib as the First-line Treatment for Locally Advanced (IIIB), Metastatic (IV) or Recurrent Pulmonary Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation.
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gefitinib Gefitinib 250mg tablet once daily	Drug: Gefitinib; 250mg tablet oral tablet once daily; Other Names: ZD1839 IRESSA

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria. [baseline to 12 months]

   Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients. RECIST criteria: CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria

Secondary Outcome Measures

1. Progression Free Survival (PFS) [baseline to 4 months]

   Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.

2. Overall Survival (OS) [baseline to 12 months]

   Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.

3. Safety Profile: Participants With Adverse Events [baseline to end of study]

   Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis

• WHO Performance Status 0-2

• No prior chemotherapy, biological or immunological therapy/surgery

Exclusion Criteria:

• Any evidence of clinically active interstitial lung disease

• Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation

• Patients with previously diagnosed and treated CNS metastases or spinal cord compression

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Seongnam-Si		Korea, Republic of
2	Research Site	Seoul		Korea, Republic of

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: HyeJong Yoo, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00344773
• Other Study ID Numbers: D7913L00056
• First Posted: Jun 27, 2006
• Last Update Posted: Jun 29, 2010
• Last Verified: Jun 1, 2010

• Keywords provided by , ,: Locally advanced (IIIB) pulmonary adenocarcinoma with EGFR mutation; Metastatic (IV) pulmonary adenocarcinoma with EGFR mutation; Recurrent pulmonary adenocarcinoma with EGFR mutation
• Additional relevant MeSH terms: Adenocarcinoma; Lung Neoplasms; Gefitinib

Study Results

Participant Flow

Recruitment Details	147 patients were screened for epidermal growth factor receptor (EGFR) mutation and 46 patients were enrolled in this study. Subjects were recruited by 7 investigational centers throughout South Korea from Mar 2006 to May 2007

Arm/Group Title	Gefitinib
Arm/Group Description	Gefitinib 250mg tablet
Period Title: Overall Study
STARTED	46
COMPLETED	25
NOT COMPLETED	21

Baseline Characteristics

Arm/Group Title	Gefitinib
Arm/Group Description	Gefitinib 250mg tablet
Overall Participants	46
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (12)
Sex: Female, Male (Count of Participants)
Female	11 23.9%
Male	35 76.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
Description	Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients. RECIST criteria: CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria
Time Frame	baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gefitinib
Arm/Group Description	Gefitinib 250mg tablet
Measure Participants	46
Number [Percent of Participants]	0 0%

2. Secondary Outcome

Title	Progression Free Survival (PFS)
Description	Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.
Time Frame	baseline to 4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gefitinib
Arm/Group Description	Gefitinib 250mg tablet
Measure Participants	46
Number [Percent of Participants]	86.25 187.5%

3. Secondary Outcome

Title	Overall Survival (OS)
Description	Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.
Time Frame	baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gefitinib
Arm/Group Description	Gefitinib 250mg tablet
Measure Participants	46
Number [Percent of Participants]	82.26 (0) 178.8%

4. Secondary Outcome

Title	Safety Profile: Participants With Adverse Events
Description	Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.
Time Frame	baseline to end of study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Gefitinib
Arm/Group Description	Gefitinib 250mg tablet
All Cause Mortality
	Gefitinib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Gefitinib
	Affected / at Risk (%)	# Events
Total	4/ (NaN)
Gastrointestinal disorders
Diarrhea	1/46 (2.2%)
Infections and infestations
Pneumonia	2/46 (4.3%)
Injury, poisoning and procedural complications
Multiple contusion with Lt.9.10.11th rib fracture	1/46 (2.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intramuscular myxoma in the left intraspinatos muscle	1/46 (2.2%)
Nervous system disorders
Myoclonus	1/46 (2.2%)
Other (Not Including Serious) Adverse Events
	Gefitinib
	Affected / at Risk (%)	# Events
Total	44/ (NaN)
Gastrointestinal disorders
Constipation	7/46 (15.2%)
Diarrhea	16/46 (34.8%)
Dyspepsia	4/46 (8.7%)
Epigastric pain	3/46 (6.5%)
Epigastric soreness	3/46 (6.5%)
General-weakness	3/46 (6.5%)
Indigestion	3/46 (6.5%)
Nausea	12/46 (26.1%)
Stomatitis	9/46 (19.6%)
Infections and infestations
Common cold	3/46 (6.5%)
Metabolism and nutrition disorders
Anorexia	17/46 (37%)
Musculoskeletal and connective tissue disorders
Back-pain	4/46 (8.7%)
Nervous system disorders
Dizziness	5/46 (10.9%)
Headache	6/46 (13%)
Neuropathy	4/46 (8.7%)
Respiratory, thoracic and mediastinal disorders
Cough	13/46 (28.3%)
Dyspnea	6/46 (13%)
Rhinorrhea	3/46 (6.5%)
Sorethroat	3/46 (6.5%)
Sputum	10/46 (21.7%)
Skin and subcutaneous tissue disorders
Alopecia	5/46 (10.9%)
Desquamation	9/46 (19.6%)
Dry-skin	3/46 (6.5%)
Hand foot syndrome	3/46 (6.5%)
Hand-foot syndrome	3/46 (6.5%)
Itching	16/46 (34.8%)
Mucositis	3/46 (6.5%)
Rash	3/46 (6.5%)
Skin-rash	14/46 (30.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.