Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Non-Small Cell Lung Cancer, Locally Advanced or Metastatic NSCL Cancer
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
Interventions
DRUGGefitinib
250 mg oral
PROCEDURECT or MRI
performed at screening and every 6 weeks
DRUGDocetaxel
60mg/m2 intravenous infusion
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients With Adverse Event (AE) | From time consent was given to 28 days after last dose of study drug. |
| Number of Patients With Serious Adverse Events (SAEs) | From time consent was given to 28 days after last dose |
Countries
Taiwan
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.
Participants by arm
| Arm | Count |
|---|---|
| Gefitinib gefitinib 250mg | 8 |
| Docetaxel docetaxel 60mg/m sq | 6 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 1 |
| Overall Study | Incorrect enrolment | 1 | 0 |
| Overall Study | Study Termination | 2 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Gefitinib | Docetaxel | Total |
|---|---|---|---|
| Age Continuous | 67.43 years STANDARD_DEVIATION 8.15 | 54.52 years STANDARD_DEVIATION 12.34 | 61.89 years STANDARD_DEVIATION 11.76 |
| BMI | 23.84 kg/m2 STANDARD_DEVIATION 3.85 | 22.77 kg/m2 STANDARD_DEVIATION 3.27 | 23.39 kg/m2 STANDARD_DEVIATION 3.52 |
| Height | 159.3 cm STANDARD_DEVIATION 7.26 | 162.77 cm STANDARD_DEVIATION 7.32 | 160.79 cm STANDARD_DEVIATION 7.22 |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
| Weight | 60.51 kg STANDARD_DEVIATION 10.35 | 60.03 kg STANDARD_DEVIATION 6.4 | 60.31 kg STANDARD_DEVIATION 8.57 |
| WHO performance status 100% bedridden | 0 participants | 0 participants | 0 participants |
| WHO performance status In bed less than or equal to 50% of time | 0 participants | 1 participants | 1 participants |
| WHO performance status In bed more than 50% of the time | 0 participants | 0 participants | 0 participants |
| WHO performance status Normal activity | 0 participants | 1 participants | 1 participants |
| WHO performance status Restricted activity | 8 participants | 4 participants | 12 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 8 | 6 / 6 |
| serious Total, serious adverse events | 2 / 8 | 1 / 6 |
Outcome results
Primary
Number of Patients With Adverse Event (AE)
Time frame: From time consent was given to 28 days after last dose of study drug.
Population: Evaluable for Safety population: All patients who recived at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Number of Patients With Adverse Event (AE) | 8 Participants |
| Docetaxel | Number of Patients With Adverse Event (AE) | 6 Participants |
Primary
Number of Patients With Serious Adverse Events (SAEs)
Time frame: From time consent was given to 28 days after last dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Number of Patients With Serious Adverse Events (SAEs) | 2 participants |
| Docetaxel | Number of Patients With Serious Adverse Events (SAEs) | 1 participants |