Maintenance ZD1839 (IRESSA®) Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer

NCT00090675 | Withdrawn Phase 3

• 2 other identifiers: D7913L00019Herbst trial
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV) who have SD or objective tumor response immediately following the completion of 4-6 cycles of front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner to receive either ZD1839 or placebo.

Conditions

Non-Small-Cell Lung Carcinoma

Interventions

ZD1839 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must sign Informed Consent
• Females and males aged 18 years and over.
• Confirmed stage IIIB (T4-pleural effusion) and IV NSCLC.
• Either complete response, partial response, or stable disease following at least 4 cycles (3 in the setting of intolerable toxicity) but no more than 6 cycles of definitive front line, platinum-based, doublet chemotherapy.
• No prior EGFR therapy
• No newly diagnosed intracerebral metastases while receiving or after completing chemotherapy
• At least 3 weeks (21 days) but no more than 4 weeks (28 days) since last dose of chemotherapy
• Must be completely healed from previous major oncologic surgery
• Life expectancy of ≥ 8 weeks.

You may not qualify if:

• Known severe hypersensitivity to ZD1839 or any of the excipients of these products.
• Any evidence of clinically active interstitial lung disease (subjects with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
• Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
• Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy excluding peripheral neuropathy or alopecia.
• Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
• Pregnancy or breast feeding (women of child bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
• Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
• Signs of neurological symptoms consistent with new onset spinal cord compression or CNS metastases.
• Males must also be willing to practice acceptable methods of birth control while taking the drug to prevent pregnancy of a partner.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Iressa Medical Science Director

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2004
• First Posted: September 3, 2004
• Study Start: January 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: January 29, 2013

Record last verified: 2013-01