An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma

NCT00787410 | Completed Phase 2

• 1 other identifier: 1839IL/0094
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multicentre, open label, non-comparative, two stage phase II trial to assess the activity of ZD1839 (IRESSA) in patients with malignant mesothelioma. Patients will receive trial treatment as first-line therapy, administered continuously once daily until the completion of six 4-week cycles of treatment, disease progression, unacceptable toxicity or withdrawal of consent. Patients continuing to show evidence of response, disease stabilization or clinical benefit from ZD1839 may continue to receive therapy beyond completion of the trail.

Conditions

Mesothelioma

Keywords

malignant mesothelioma; IRESSA; ZD1839

Outcome Measures

Primary Outcomes (2)

• To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure

  Proportion of patients responding at trial closure, ITT population

• To further characterize the safety profile of ZD1839 at a 250mg daily dose

  Proportion of patients responding at trial closure, ITT population

Secondary Outcomes (3)

• To estimate PFS (progression free survival)

  Proportion of patients alive and progression-free at trial closure, ITT population; Median time to progression or death; Proportion of patients alive and progression-free at 6 months

• To estimate overall survival

  Proportion of patients alive at trial closure, ITT population; Median time to death; Proportion of patients alive at 6 months

• To estimate duration of response

  Median time from objective response to progression or death; only patients who responded are included in this analysis

Study Arms (1)

1

EXPERIMENTAL

Drug: ZD1839

Interventions

ZD1839 DRUG

250mg tablet, once daily, orally administered

Also known as: IRESSA

1

Eligibility Criteria

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

You may qualify if:

• Histologically-confirmed malignant mesothelioma (based on pleural biopsy); eligibility for first line therapy for malignant mesothelioma
• Uni or bi- dimensionally measurable disease
• No prior radiotherapy within 3 weeks of enrolment into the trial
• No significant comorbid disease

You may not qualify if:

• Other malignancies, either co-existing or diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
• Brian metastasis or leptomeningeal carcinomatosis
• Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
• Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, or St. John's Wort

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Mesothelioma; Mesothelioma, Malignant

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Christopher Lee, MD

  Fraser Valley Cancer Centre Surrey Memorial Hospital, Surrey BC, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: September 1, 2003
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 6, 2012

Record last verified: 2012-06