Study to Assess Safety/Tolerability/Efficacy of Gefitinib Versus Docetaxel in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

• Sponsor: AstraZeneca (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00536107
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This is a randomized, open- label, parallel group, phase IV, multicentre study. The total number of patients expected to be recruited is 40. These randomized patients will have a histologically or cytologically confirmed adenocarcinoma histology of locally advanced or metastatic NSCLC. Patients will be recruited by investigational sites that have expertise in treating patients with non-small cell lung cancer. The study will compare gefitinib monotherapy 250 mg/day orally with docetaxel 60 mg/m2 intravenously over 1 hour every 3 weeks with a primary endpoint of safety and tolerability. The target population will be patients who have received one prior platinum-based chemotherapy and are now considered suitable candidates for further chemotherapy with docetaxel. At study entry, patients will be randomized on a 1:1 basis stratified with respect to performance status (0-1 vs. 2). Patients may continue to receive treatment with either gefitinib or docetaxel until disease progression, unacceptable toxicity or the occurrence of any of the other specific criteria. An independent committee will be appointed to perform a blinded review of all patient scans. Any assessments/visits after screening should be performed within a window of plus or minus 3 working days of the scheduled visit date. If selected screening evaluations are done within 7 days of Day 1, Cycle 1 of treatment, and are acceptable for study entry, they do not have to be repeated on Day 1 unless the investigator believes that they are likely to have significantly changed. Any patient who discontinues from study treatment without radiological evidence of disease progression (except for withdrawal of consent by patient) should continue to have objective tumor assessments every 6 weeks in order to collect information on progression of disease

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Gefitinib; Procedure: CT or MRI; Drug: Docetaxel	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized/Open Label/Parallel Group/Multicenter/Phase IV Study to Assess Safety/Tolerability/Efficacy of Oral Gefitinib 250 mg Versus IV Docetaxel 60 mg/m2 in Patients With Locally Advanced or Metastatic NSCL Cancer of Adenocarcinoma Histology Previous Treated With One Platinum Base Chemotherapy
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Docetaxel docetaxel	Procedure: CT or MRI; performed at screening and every 6 weeks; Drug: Docetaxel; 60mg/m2 intravenous infusion; Other Names: Paxel
Experimental: Gefitinib Gefitinib (IRESSA)	Drug: Gefitinib; 250 mg oral; Other Names: IRESSA ; Procedure: CT or MRI; performed at screening and every 6 weeks

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Adverse Event (AE) [From time consent was given to 28 days after last dose of study drug.]

2. Number of Patients With Serious Adverse Events (SAEs) [From time consent was given to 28 days after last dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC, not amenable to curative surgery or radiotherapy

• Treatment with one prior chemotherapy regimen, which must have been platinum based* *Patients must have demonstrated radiological or clinical progression since completion of previous chemotherapy regimen.

• Adequate hepatic function, defined as BOTH a bilirubin < upper limit of reference range (ULRR) AND an "Eligible" combination of transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) and alkaline phosphatase (ALP) below: Not Eligible: AST or ALT > 5xULRR, 1.5xULRR < AST or ALT < 5xULRR and ALP> ULRR, 1xULRR < AST or ALT < 1.5xULRR and ALP> 2.5xULRR, AST or ALT <= ULRR and ALP> 5xULRR For more information please refer to TAXOTERE® (docetaxel) prescribing information

Exclusion Criteria:

• Prior therapy with gefitinib or other EGFR TK inhibitors (HER-1 receptor inhibitors/small molecule or monoclonal antibody therapy)

• Prior docetaxel treatment for NSCLC

• Patients with pre-existing peripheral neuropathy ³ grade 2 (NCI CTCAE criteria)

• Past medical history of interstitial lung disease, drug induced interstitial disease, radiation pneumonitis that required steroid treatment or any evidence of clinically active interstitial lung disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Taipei		Taiwan

Sponsors and Collaborators

• AstraZeneca

Investigators

• Principal Investigator: Han-Pin Kuo, MD, Director of Chest Department, Chang Gung Memorial Hospital, Linkou

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00536107
• Other Study ID Numbers: D7913C00046
• First Posted: Sep 27, 2007
• Last Update Posted: Oct 1, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by AstraZeneca: Non-Small Cell Lung Cancer; Locally Advanced or Metastatic NSCL Cancer
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung; Docetaxel; Gefitinib

Study Results

Participant Flow

Recruitment Details	A total of 14 patients with locally advanced or metastatic non small cell lung cancer of adenocarcinoma histology previously treated with one platinum based chemotherapy were screened and randomized.

Arm/Group Title	Gefitinib	Docetaxel
Arm/Group Description	gefitinib 250mg	docetaxel 60mg/m sq
Period Title: Overall Study
STARTED	8	6
COMPLETED	0	0
NOT COMPLETED	8	6

Baseline Characteristics

Arm/Group Title	Gefitinib	Docetaxel	Total
Arm/Group Description	gefitinib 250mg	docetaxel 60mg/m sq	Total of all reporting groups
Overall Participants	8	6	14
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.43 (8.15)	54.52 (12.34)	61.89 (11.76)
Sex: Female, Male (Count of Participants)
Female	4 50%	3 50%	7 50%
Male	4 50%	3 50%	7 50%
WHO performance status (participants) [Number]
Normal activity	0 0%	1 16.7%	1 7.1%
Restricted activity	8 100%	4 66.7%	12 85.7%
In bed less than or equal to 50% of time	0 0%	1 16.7%	1 7.1%
In bed more than 50% of the time	0 0%	0 0%	0 0%
100% bedridden	0 0%	0 0%	0 0%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	60.51 (10.35)	60.03 (6.4)	60.31 (8.57)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	159.3 (7.26)	162.77 (7.32)	160.79 (7.22)
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	23.84 (3.85)	22.77 (3.27)	23.39 (3.52)

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Adverse Event (AE)
Time Frame	From time consent was given to 28 days after last dose of study drug.

Outcome Measure Data

Analysis Population Description

Evaluable for Safety population: All patients who recived at least one dose of study drug

Arm/Group Title	Gefitinib	Docetaxel
Arm/Group Description	gefitinib 250mg	docetaxel 60mg/m sq
Measure Participants	8	6
Number [Participants]	8 100%	6 100%

2. Primary Outcome

Title	Number of Patients With Serious Adverse Events (SAEs)
Time Frame	From time consent was given to 28 days after last dose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gefitinib	Docetaxel
Arm/Group Description	gefitinib 250mg	docetaxel 60mg/m sq
Measure Participants	8	6
Number [participants]	2 25%	1 16.7%

Adverse Events

Time Frame	From time consent was given to 28 days after last dose of study drug
Adverse Event Reporting Description	Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Arm/Group Title	Gefitinib		Docetaxel
Arm/Group Description	gefitinib 250mg		docetaxel 60mg/m sq
All Cause Mortality
	Gefitinib		Docetaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Gefitinib		Docetaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/8 (25%)		1/6 (16.7%)
Eye disorders
Glaucoma	1/8 (12.5%)		0/6 (0%)
Infections and infestations
Pneumonia	1/8 (12.5%)		0/6 (0%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/8 (0%)		1/6 (16.7%)
Other (Not Including Serious) Adverse Events
	Gefitinib		Docetaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/8 (100%)		6/6 (100%)
Blood and lymphatic system disorders
Anaemia	0/8 (0%)		1/6 (16.7%)
Neutropenia	0/8 (0%)		1/6 (16.7%)
Eye disorders
Borderline glaucoma	1/8 (12.5%)		0/6 (0%)
Iridocyclitis	1/8 (12.5%)		0/6 (0%)
Gastrointestinal disorders
Abdominal pain upper	0/8 (0%)		2/6 (33.3%)
Aphthous stomatitis	1/8 (12.5%)		0/6 (0%)
Constipation	1/8 (12.5%)		1/6 (16.7%)
Diarrhoea	1/8 (12.5%)		0/6 (0%)
Nausea	0/8 (0%)		2/6 (33.3%)
Vomiting	1/8 (12.5%)		2/6 (33.3%)
General disorders
Asthenia	0/8 (0%)		1/6 (16.7%)
Chest discomfort	1/8 (12.5%)		0/6 (0%)
Fatigue	0/8 (0%)		1/6 (16.7%)
Malaise	0/8 (0%)		1/6 (16.7%)
Oedema peripheral	1/8 (12.5%)		1/6 (16.7%)
Pyrexia	1/8 (12.5%)		0/6 (0%)
Infections and infestations
Bronchitis	1/8 (12.5%)		0/6 (0%)
Catheter site infection	1/8 (12.5%)		0/6 (0%)
Nasopharyngitis	0/8 (0%)		1/6 (16.7%)
Oral candidiasis	1/8 (12.5%)		0/6 (0%)
Pneumonia	0/8 (0%)		1/6 (16.7%)
Sepsis	1/8 (12.5%)		0/6 (0%)
Tonsillitis	0/8 (0%)		1/6 (16.7%)
Upper respiratory tract infection	1/8 (12.5%)		1/6 (16.7%)
Injury, poisoning and procedural complications
Wound complication	1/8 (12.5%)		0/6 (0%)
Wound dehiscence	1/8 (12.5%)		0/6 (0%)
Investigations
Alanine aminotransferase increased	1/8 (12.5%)		0/6 (0%)
Aspartate aminotransferase increased	1/8 (12.5%)		0/6 (0%)
Neutrophil count decreased	0/8 (0%)		1/6 (16.7%)
White blood cell count decreased	0/8 (0%)		1/6 (16.7%)
Metabolism and nutrition disorders
Anorexia	1/8 (12.5%)		1/6 (16.7%)
Hyponatraemia	0/8 (0%)		1/6 (16.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/8 (12.5%)		0/6 (0%)
Bone pain	1/8 (12.5%)		0/6 (0%)
Muscle spasms	1/8 (12.5%)		1/6 (16.7%)
Muscular weakness	0/8 (0%)		1/6 (16.7%)
Musculoskeletal disorder	1/8 (12.5%)		0/6 (0%)
Myalgia	0/8 (0%)		1/6 (16.7%)
Nervous system disorders
Convulsion	0/8 (0%)		1/6 (16.7%)
Dizziness	1/8 (12.5%)		3/6 (50%)
Hypoaesthesia	1/8 (12.5%)		1/6 (16.7%)
Paraplegia	1/8 (12.5%)		0/6 (0%)
Psychiatric disorders
Insomnia	0/8 (0%)		1/6 (16.7%)
Renal and urinary disorders
Bladder disorder	1/8 (12.5%)		0/6 (0%)
Dysuria	0/8 (0%)		1/6 (16.7%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/8 (12.5%)		0/6 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/8 (12.5%)		0/6 (0%)
Cough	0/8 (0%)		1/6 (16.7%)
Dysphonia	1/8 (12.5%)		1/6 (16.7%)
Dyspnoea	0/8 (0%)		1/6 (16.7%)
Dyspnoea exertional	1/8 (12.5%)		1/6 (16.7%)
Epistaxis	1/8 (12.5%)		1/6 (16.7%)
Haemoptysis	1/8 (12.5%)		1/6 (16.7%)
Lung disorder	1/8 (12.5%)		0/6 (0%)
Obstructive airways disorder	1/8 (12.5%)		0/6 (0%)
Rhinorrhoea	0/8 (0%)		1/6 (16.7%)
Throat Irritation	1/8 (12.5%)		0/6 (0%)
Skin and subcutaneous tissue disorders
Acne	1/8 (12.5%)		0/6 (0%)
Alopecia	0/8 (0%)		2/6 (33.3%)
Dry skin	3/8 (37.5%)		0/6 (0%)
Pain of skin	1/8 (12.5%)		0/6 (0%)
Pruritus	4/8 (50%)		0/6 (0%)
Rash	1/8 (12.5%)		0/6 (0%)
Vascular disorders
Hypertension	0/8 (0%)		1/6 (16.7%)

Limitations/Caveats

This study was terminated early because the purpose of this study had been fulfilled by other supporting data, and due to small number of patients enrolled (14 patients).

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.