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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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000706673
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
2/11/2005
Date last updated
28/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase II CPT-11, LV and 5FU in Gastric Cancer
Scientific title
A PHASE II STUDY OF IRINOTECAN, LEUCOVORIN AND FLUOROURACIL IN ADVANCED GASTRIC CANCER TO IMPROVE DISEASE FREE SURVIVAL
Secondary ID [1] 214 0
Australasian Gastro-Intestinal Trials Group: AG9801
Secondary ID [2] 215 0
National Clinical Trials Registry: NCTR338
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 856 0
Condition category
Condition code
Cancer 922 922 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chemotherapy: CPT-11, Leucovorin, 5FU. All drugs will be given in repeated six-week courses comprising weekly therapy for four weeks followed by a two-week rest period.
Intervention code [1] 566 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1207 0
Objective Response Rate
Timepoint [1] 1207 0
Every 3 months
Secondary outcome [1] 2205 0
Toxicity
Timepoint [1] 2205 0
Post every cycle of chemotherapy.

Eligibility
Key inclusion criteria
Patients must have clinically documented locally advanced or metastatic adenocarcinoma of the stomach and histologic confirmation of the diagnosis. Patients must have measurable disease (lesions > 1x1 cm by clinical measurement or chest x-ray, and > 2x2 cm by CT or ultrasound). Patients must have a performance status of 0-2 on the ECOG Performance Scale. Patients must have a predicted life expectancy of at least 12 weeks. Patients must have a pre-treatment granulocyte count (ie., segmented neutrophils + bands) of > 1.5 x 109/L, a haemoglobin level of 90 gm/L and a platelet count of > 100 x 109/L. Patients must have adequate renal function as documented by a serum creatinine 200 mol/L. Patients must have adequate hepatic function as documented by a serum bilirubin 25 mol/L, regardless of whether patients have liver involvement secondary to tumour. Aspartate transaminase (AST, SGOT) must be 3x institutional upper limit of normal unless the liver is involved with tumour, in which case the aspartate transaminase must be 5x institutional upper limit of normal. Patients must be and geographically assessable and physically capable of completing study investigations as required. Patients must give written informed consent.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have previously received CPT-11 or topotecan. Patients who have received chemotherapy in both the neoadjuvant / adjuvant setting and for recurrent/metastatic disease. (Prior chemotherapy is permitted under certain conditions see section 8.1). Patients with any active or uncontrolled infection, including known HIV infection. Patients with psychiatric disorders that would interfere with consent or follow up. Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy. Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least five years. Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Presence of clinically apparent central nervous system metastases or carcinomatous meningitis. Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other antiepileptic prophylaxis are ineligible. Patients with uncontrolled diabetes mellitus, defined as random blood sugar > 15 mmol/L. Patients with baseline serum calcium 2.70 mmol/L. Patients with known Gilbert's Disease, as these patients may have excessive CPT-11-induced toxicity. Patients with any other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1017 0
Commercial sector/Industry
Name [1] 1017 0
Pharmacia
Address [1] 1017 0
Country [1] 1017 0
Primary sponsor type
Other Collaborative groups
Name
Site - Investigator Initiated . AGITG sponsored trial, conducted through NHMRC CTC
Address
Country
Australia
Secondary sponsor category [1] 880 0
Other Collaborative groups
Name [1] 880 0
AGITG
Address [1] 880 0
Country [1] 880 0
Australia
Secondary sponsor category [2] 881 0
University
Name [2] 881 0
NHMRC Clinical Trials Centre
Address [2] 881 0
Country [2] 881 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35611 0
Address 35611 0
Country 35611 0
Phone 35611 0
Fax 35611 0
Email 35611 0
Contact person for public queries
Name 9755 0
Burcu Cakir
Address 9755 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 9755 0
Australia
Phone 9755 0
+61 2 95625334
Fax 9755 0
+61 2 95625094
Email 9755 0
bcakir@ctc.usyd.edu.au
Contact person for scientific queries
Name 683 0
Stephen Ackland
Address 683 0
Locked Bag 77
Camperdown NSW 1450
Country 683 0
Australia
Phone 683 0
+61 2 95625334
Fax 683 0
+61 2 95625094
Email 683 0
mdspa@cc.newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary