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CompletedNCT00062257Updated May 15, 2013

Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer

A Phase 2 interventional study of irofulven in Gastric Cancer, sponsored by Cancer Therapeutics Research Group. Completed at 6 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-15.

Sponsored by Cancer Therapeutics Research Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

  • Determine the response rate of patients with recurrent or metastatic gastric cancer treated with irofulven.
  • Determine the toxicity profile of this drug in these patients.
  • Determine the overall survival of patients treated with this drug.

OUTLINE: This is a non-randomized, open-label, multicenter study.

Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression, unacceptable toxicity, or static disease after 4 courses in the absence of clinical benefit.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 5-9 months.

02

Conditions studied

  • Gastric Cancer

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Keywords

  • recurrent gastric cancer
  • stage IV gastric cancer
  • adenocarcinoma of the stomach
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

Browse Stomach Neoplasms studies →

Lead sponsor

Cancer Therapeutics Research Group is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • Drugirofulven
06

Study locations

6 sites
  • Sydney Cancer Centre at Royal Prince Alfred Hospital
    Sydney, New South Wales 2050, Australia
  • Prince of Wales Hospital
    Shatin, New Territories, Hong Kong
  • Yonsei Cancer Center at Yonsei University Medical Center
    Seoul, 120-752, Korea, Republic of
  • Cancer Institute at National University Hospital
    Singapore, 119074, Singapore
  • Johns Hopkins - Singapore
    Singapore, 119074, Singapore
  • National Cancer Centre - Singapore
    Singapore, 169610, Singapore
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00062257
Lead sponsor
Cancer Therapeutics Research Group
Collaborators
National Cancer Institute (NCI)
First posted
Jun 6, 2003
Start date
Jun 2003
Completion
Sep 2006
Last update
May 15, 2013

Study contacts

Winnie Yeo
study chair · Prince of Wales Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2005. You cannot join it, but the record below documents what was studied.

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