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

October 5, 2005
December 14, 2007
November 2003
Not Provided
Determine the progression free survival
Same as current
Complete list of historical versions of study NCT00234429 on ClinicalTrials.gov Archive Site
Determine objective tumor response
Same as current
Not Provided
Not Provided
 
A Phase 2 Study of Tomudex & Iressa as Second Line Chemotherapy in Subjects With Colorectal Carcinoma
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Colorectal Cancer
Drug: Gefitinib, raltitrexed
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
June 2006
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00234429
1839IL/0143
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Spain Medical Director, MD AstraZeneca
AstraZeneca
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP