Status:
WITHDRAWN
Maintenance ZD1839 (IRESSA®) Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ob...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Treatment with any systemic anticancer therapies other than the prescribed protocol chemotherapy regimen (refer to Inclusion criterion -). Exception: Palliative radiotherapy for symptom relief of lesions present at diagnosis will be allowed; however, this radiotherapy must occur prior to completion of pre-study doublet chemotherapy.
- Males must also be willing to practice acceptable methods of birth control while taking the drug to prevent pregnancy of a partner.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00090675
Start Date
January 1 2006
End Date
November 1 2007
Last Update
January 29 2013
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