Clinical trial NCT00252798: ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
Official title: A Phase I Trial to Evaluate ZD1839(Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non Small Cell Lung Carcinoma
Keywords: Non Small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the trial is to determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 paclitaxel.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically or cytologically confirmed locally advanced stage IIIA or IIIB NSCLC (without pleural effusion)
* Patients with apical tumours and supraclavicular nodes are acceptable if both can be easily encompassed in one radiation field
* Minimum life expectancy with treatment of 6 months
* WHO performance status 0-1

Exclusion Criteria:

* Patients with previous malignancies other than NSCLC
* Previous radiotherapy for NSCLC
* Previous immunotherapy or chemotherapy
* Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
* Forced expiratory volume in 1 second (FEV1) less than 1 litre (L)
* Absolute neutrophil count (ANC) less than 1.5 x 109/L or platelets less than 100 x 109/L
* Serum bilirubin greater than 1.25 times the upper limit of reference range
* ALT or AST greater than 2.5 times the ULRR

Primary outcomes:
measure: To determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 paclitaxel.
Secondary outcomes:
measure: To evaluate the activity potential of the combination of ZD1839, carboplatin, paclitaxel & radiation therapy
measure: Estimating the objective response rate (complete response [CR] & partial response [PR]) as assessed by positron emission tomography with (18F)-labelled fluorodeoxyglucose (PET-FDG)
measure: To estimate the objective response rate (CR and PR) as assessed by computerised tomography (CT) scan
measure: To estimate the complete response rate (CR) as assessed by PET-FDG
measure: To estimate progression free survival (PFS) as assessed by clinical examination, chest x-ray, CT scan ± PET-FDG
measure: To estimate overall survival
measure: To characterise the safety and tolerability of ZD1839 combined with concurrent carboplatin, paclitaxel and radiation
measure: To determine the site of first failure (characterised as local-regional, distant or both)
Other outcomes:
Locations:
city: Woolloonabba
country: Australia
facility: Research Site
state: Queensland
city: East Melbourne
country: Australia
facility: Research Site
state: Victoria
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Australia Medical Director, MD
role: STUDY_DIRECTOR
References: