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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00234429

Collaborator

(none)

Enrollment

Locations

Duration (Months)

8.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Nov 1, 2003

Actual Study Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

Determine the progression free survival []

Secondary Outcome Measures

Determine objective tumor response []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Research Site	A Coruna	Spain
2	Research Site	Barcelona	Spain
3	Research Site	Burgos	Spain
4	Research Site	Gijon	Spain
5	Research Site	Leon	Spain
6	Research Site	Madrid	Spain
7	Research Site	Oviedo	Spain
8	Research Site	Pamplona	Spain
9	Research Site	Valladolid	Spain