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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00062257




Registration number
NCT00062257
Ethics application status
Date submitted
5/06/2003
Date registered
6/06/2003
Date last updated
15/05/2013

Titles & IDs
Public title
Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer
Scientific title
A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer
Secondary ID [1] 0 0
CDR0000304669
Secondary ID [2] 0 0
CTRG-G15/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - irofulven

Treatment: Drugs: irofulven
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed gastric adenocarcinoma

- Recurrent or metastatic disease

- Adenocarcinoma of the gastroesophageal junction eligible provided the majority of
tumor bulk is below the junction

- Measurable disease

- At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by
spiral CT scan

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-2

Life expectancy

- More than 3 months

Hematopoietic

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- No active disseminated intravascular coagulation

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST/ALT no greater than 2.5 times ULN (5 times ULN for patients with liver metastases)

- Alkaline phosphatase no greater than 5 times ULN

Renal

- Creatinine no greater than 1.5 times ULN

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior allergic reaction attributed to compounds of similar chemical or biological
composition to irofulven

- No other malignancy within the past 5 years except adequately treated carcinoma in
situ of the cervix or basal cell or squamous cell skin cancer

- No other uncontrolled concurrent illness that would preclude study participation

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- Must have central or peripherally inserted central catheter

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa

Chemotherapy

- No prior chemotherapy for recurrent or metastatic disease

- Prior adjuvant or neoadjuvant chemotherapy allowed provided disease relapsed more than
6 months after therapy

Endocrine therapy

- Not specified

Radiotherapy

- More than 4 weeks since prior radiotherapy and recovered

Surgery

- Not specified

Other

- No other concurrent investigational or commercial agents or therapies for the
malignancy

- No concurrent combination antiretroviral therapy for HIV-positive patients
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Shatin, New Territories
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seoul
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
Cancer Therapeutics Research Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy, such as irofulven, use different ways to stop tumor
cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well irofulven works in treating patients with
recurrent or metastatic gastric cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00062257
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Winnie Yeo
Address 0 0
Prince of Wales Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00062257