Working… Menu

A Phase 2 Study of Tomudex & Iressa as Second Line Chemotherapy in Subjects With Colorectal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234429
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : December 18, 2007
Information provided by:

Brief Summary:
The primary objective of this study is to compare the activity of raltitrexed and ZD1839 versus raltitrexed alone as second line chemotherapy in subjects with colorectal carcinoma by estimating progression free survival (PFS) in each treatment arm.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Gefitinib, raltitrexed Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind Phase 2b Study of Raltitrexed (Tomudex) and ZD1839 (Iressa) Versus Raltitrexed Alone as Second Line Chemotherapy in Subjects With Colorectal Carcinoma
Study Start Date : November 2003
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Primary Outcome Measures :
  1. Determine the progression free survival

Secondary Outcome Measures :
  1. Determine objective tumor response

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, aged 18 to 75 years, inclusive
  • histologically-confirmed metastatic colorectal carcinoma; measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST)
  • relapsed after treatment with a fluoropyrimidine-based chemotherapy
  • prior chemotherapeutic regimen for metastatic or locally advanced disease with an interval of at least 4 weeks between the last administration of chemotherapy an the first administration of study treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • life expectancy of at least 12 weeks

Exclusion Criteria:

  • Known severe hypersensitivity to raltitrexed or any of the excipients of this product
  • known severe hypersensitivity to raltitrexed or any of the excipients of this product
  • active infection or uncontrolled diarrhoea
  • cerebral metastasis or meningeal carcinomatosis
  • any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
  • simultaneous antitumoral treatment
  • radiotherapy within 2 weeks before entry into the study
  • 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 common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
  • significant clinical disorder or laboratory finding (leukocyte count less than 3.0 x 109 /litre (L) or platelets less than 100 x 109 /L; serum total bilirubin more than 2.0 mg/dl; as judged by investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease); creatinine clearance ≥ 65ml/min (according to Cockcroft-Gault formula); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times the upper limit of the reference range (ULRR) if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases)
  • pregnancy or breast feeding (women of child-bearing potential)
  • concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or ST John's Wort;
  • Treatment with a non- approved or investigational drug within 30 days before Day 1 of study treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00234429

Layout table for location information
Research Site
A Coruna, Spain
Research Site
Barcelona, Spain
Research Site
Burgos, Spain
Research Site
Gijon, Spain
Research Site
Leon, Spain
Research Site
Madrid, Spain
Research Site
Oviedo, Spain
Research Site
Pamplona, Spain
Research Site
Valladolid, Spain
Sponsors and Collaborators
Layout table for investigator information
Study Director: AstraZeneca Spain Medical Director, MD AstraZeneca

Layout table for additonal information Identifier: NCT00234429     History of Changes
Other Study ID Numbers: 1839IL/0143
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: December 18, 2007
Last Verified: December 2007
Keywords provided by AstraZeneca:
Colorectal carcinoma advanced disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Folic Acid Antagonists