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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00234429
First received: October 5, 2005
Last updated: December 14, 2007
Last verified: December 2007
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: Gefitinib, raltitrexed
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Determine the progression free survival

Secondary Outcome Measures:
  • Determine objective tumor response

Estimated Enrollment: 74
Study Start Date: November 2003
Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00234429

Locations
Spain
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
AstraZeneca
Investigators
Study Director: AstraZeneca Spain Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00234429     History of Changes
Other Study ID Numbers: 1839IL/0143
Study First Received: October 5, 2005
Last Updated: December 14, 2007
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
Colorectal carcinoma advanced disease

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Raltitrexed
Gefitinib
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014