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OpenTrials
Completed

NCT Number: NCT00787410

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ZD1839

Drug

250mg tablet, once daily, orally administered

Other names: IRESSA

Primary outcomes

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

    Time frame: Proportion of patients responding at trial closure, ITT population

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

    Time frame: Proportion of patients responding at trial closure, ITT population

Secondary outcomes

  1. To estimate PFS (progression free survival)

    Time frame: 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

  2. To estimate overall survival

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

  3. To estimate duration of response

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Nov 7, 2008
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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