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A Phase I/II, Multicentre Clinical Study Of ZD1839 (Iressa™) In Combination With Capecitabine (Xeloda™) In Subjects With Advanced Colorectal Carcinoma After Failure Of First-Line Chemotherapy

Phase 1/Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

A Phase I/II, Multicentre Clinical Study Of ZD1839 (Iressa™) In Combination With Capecitabine (Xeloda™) In Subjects With Advanced Colorectal Carcinoma After Failure Of First-Line Chemotherapy

Inclusion Criteria:

- 18 years or older, Histologically-confirmed colorectal carcinoma, Non-resectable
metastatic or locally advanced disease, Objective progression after one prior
chemotherapeutic regimen for metastatic or locally advanced disease with an interval
of at least 4 weeks between the last administration of chemotherapy and the first
administration of study treatment, Measurable lesion according to the RECIST, life
expectancy more than 12 weeks, World Health Organisation (WHO) performance status of
0, 1 or 2.

Exclusion Criteria:

- 1. Prior adjuvant chemotherapy if the disease-free interval is less than 6 months
Known leptomeningeal or central nervous system (CNS) metastases Known severe
hypersensitivity to ZD1839 or any of the excipients of this product Known, severe
hypersensitivity to capecitabine or any of the excipients of this product 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 CTC grade 1 from previous anticancer therapy Absolute neutrophil count
(ANC) less than 1500 mm3 (1.5 x 109/litre [L]), platelets less than 100 000 mm3 (100
x 109/L) or haemoglobin less than 10 g/dl Serum bilirubin greater than 1.5 times the
upper limit of the reference range (ULRR) Serum creatinine greater than 1.25 times
the ULRR Creatinine clearance below 30 mL/min (Cockroft and Gault) Alkaline
phosphatase (ALP) greater than 5 times the ULRR or greater than 20 times the ULRR in
subjects with known bone metastasesAlanine aminotransferase (ALT) or aspartate
aminotransferase (AST) greater than 2.5 times the ULRR if no demonstrable liver
metastases, or greater than 5 times the ULRR in the presence of liver metastases
Prothrombin time (PT) or activated partial thromboplastin time (aPTT) less than 70%
normal laboratory value As judged by the investigator, any evidence of severe or
uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac,
hepatic, or renal disease) Evidence of any other 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) Concomitant use
of phenytoin, carbamazepine, rifampicin or barbiturates Treatment with a non-approved
or investigational drug within 30 days before Day 1 of study treatment

Type of Study:


Study Design:

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

Outcome Measure:

Objective tumour response (CR and PR) at study closure based on the RECIST

Principal Investigator

AstraZeneca Spain Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:



Spain: Spanish Agency of Medicines

Study ID:




Start Date:

February 2004

Completion Date:

November 2005

Related Keywords:

  • Colorectal Cancer
  • Colorectal Cancer
  • Colorectal Neoplasms