A Randomized, Open Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non Small Cell Lung Cancer who have Previously Received Platinum Based Chemotherapy - INTEREST

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-002943-28-LV
• Date of registration: 17/11/2004
• Prospective Registration: No
• Primary sponsor: AstraZeneca AB
• Public title: A Randomized, Open Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non Small Cell Lung Cancer who have Previously Received Platinum Based Chemotherapy - INTEREST
• Scientific title: A Randomized, Open Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non Small Cell Lung Cancer who have Previously Received Platinum Based Chemotherapy - INTEREST
• Date of first enrolment: 12/11/2004
• Target sample size: 1440
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002943-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Estonia, Latvia

Key inclusion & exclusion criteria

Inclusion criteria:
1.Provision of written informed consent
2.Age 18 years or older
3.Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Note: sputum cytology alone is not acceptable. Cytological specimens obtained by brushing, washing or needle aspiration of a defined lesion are acceptable
4.Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
5.One or two prior chemotherapy regimens, at least one of which must have been platinum-based.
6.Measurable (uni-dimensional) disease by RECIST criteria in a lesion not previously irradiated or non-measurable disease
7.WHO performance status (PS) 0-2
8.Absolute Neutrophil Count (ANC) greater than 1.5 x 10 to the power of 9/liter (L) and platelets greater than 100 x 10 to the power of 9/L
9.Adequate hepatic function, defined as BOTH a bilirubin less than or equal to upper limit of reference range (ULRR) AND an “Eligible” combination of transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) and alkaline phosphatase (ALP).
10.Recovery from all acute toxicities of prior therapies
11.Life expectancy of at least 8 weeks

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.Prior ZD1839 therapy or prior therapy with an experimental agent whose primary mechanism of action is inhibition of EGFR or its associated tyrosine kinase
2.Prior docetaxel treatment for NSCLC
3.Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days
4.Less than 14 days since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
5.Less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
6.Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion of the investigator, makes it inappropriate for the patient to be enrolled in the study
7.Known severe hypersensitivity to ZD1839 or any of the excipients of this product
8.Known hypersensitivity to docetaxel, polysorbate 80 or other drugs formulated with polysorbate 80, or any of the excipients of docetaxel
9.Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
10.Unable to swallow tablets
11.Any evidence of clinically active ILD (patients with chronic, stable, radiographic changes who are asymptomatic or patients with uncomplicated progressive lymphangitic carcinomatosis need not be excluded)
12.As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
13.Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
14.Incomplete healing of the surgical incision from prior major surgery (small biopsy wounds will not prohibit the patient from study entry)
15.Signs of neurological symptoms consistent with new onset spinal cord compression
16.Patients with pre-existing peripheral neuropathy greater than or equal to grade 2 (NCI CTC criteria)
17.Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control throughout the study to prevent pregnancy
18.Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates or St John’s Wort
19.Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer

Intervention(s)

Product Name: Iressa
Product Code: ZD1839
Pharmaceutical Form: Tablet
Current Sponsor code: ZD1839
Other descriptive name: Iressa (gefitinib)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Trade Name: Taxotere
Product Name: Docetaxelum
Pharmaceutical Form: Intravenous infusion

Primary Outcome(s)

Main Objective: To compare overall survival between ZD1839 and docetaxel

Primary end point(s): The primary objective of this study is to compare the overall survival between ZD1839 and docetaxel. The goal is to demonstrate non-inferior or superior survival for ZD1839 compared with docetaxel.

Secondary Objective: 1. To compare TTP between ZD1839 and docetaxel
2. To compare progression-free rates at 4 months and 6 months between ZD1839 and docetaxel
3. To compare the overall objective tumor response rate between ZD1839 and docetaxel
4. To compare patient-reported functionality (PRF) and QoL between ZD1839 and docetaxel
5. To compare safety and tolerability of ZD1839 and docetaxel

Secondary ID(s)

1839IL/0721