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IRESSA™ In Combo With Xeloda™ in Advanced Colorectal Cancer Patients After 1st-Line Chemo Failure

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00242788
First received: October 20, 2005
Last updated: April 22, 2009
Last verified: April 2009
  Purpose

The primary objective of the Phase I part of the study is to determine the recommended dose of capecitabine to be administered in combination with ZD1839 250 mg orally once daily in subjects with advanced or metastatic colorectal cancer by assessing DLTs.

The primary objective of the Phase II part of the study is to estimate the objective response rate (complete response [CR] and partial response [PR]) at study closure for ZD1839 administered in combination with capecitabine in subjects with advanced or metastatic colorectal cancer using the Response Evaluation Criteria in Solid Tumours (RECIST).


Condition Intervention Phase
Colorectal Cancer
Drug: Gefitinib and capecitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Objective tumour response (CR and PR) at study closure based on the RECIST

Secondary Outcome Measures:
  • Incidence of controlled disease (CR, PR and SD) at study closure

Estimated Enrollment: 40
Study Start Date: February 2004
Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242788

Locations
Spain
Research Site
Gerona, Spain
Research Site
Leganes, Spain
Research Site
Madrid, Spain
Research Site
Malaga, Spain
Research Site
Santander, Spain
Research Site
Zaragoza, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Spain Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00242788     History of Changes
Other Study ID Numbers: 1839IL/0505
Study First Received: October 20, 2005
Last Updated: April 22, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Capecitabine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014