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


Phase 2
18 Years
N/A
Not Enrolling
Both
Mesothelioma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Proportion of patients responding at trial closure, ITT population

Safety Issue:

No

Principal Investigator

Christopher Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Canada: Health Canada

Study ID:

1839IL/0094

NCT ID:

NCT00787410

Start Date:

September 2003

Completion Date:

April 2008

Related Keywords:

  • Mesothelioma
  • malignant mesothelioma
  • IRESSA
  • ZD1839
  • Mesothelioma

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