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Trial record 9 of 20 for:    Irofulven

Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00062257
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : May 15, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: irofulven Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer
Study Start Date : June 2003
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months


  • 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


  • 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


  • Creatinine no greater than 1.5 times ULN


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • 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


Biologic therapy

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


  • 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


  • More than 4 weeks since prior radiotherapy and recovered


  • Not specified


  • No other concurrent investigational or commercial agents or therapies for the malignancy
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00062257

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Australia, New South Wales
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, Korea, Republic of, 120-752
Cancer Institute at National University Hospital
Singapore, Singapore, 119074
Johns Hopkins - Singapore
Singapore, Singapore, 119074
National Cancer Centre - Singapore
Singapore, Singapore, 169610
Sponsors and Collaborators
Cancer Therapeutics Research Group
National Cancer Institute (NCI)
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Study Chair: Winnie Yeo Prince of Wales Hospital

Layout table for additonal information Identifier: NCT00062257     History of Changes
Other Study ID Numbers: CTRG-G15/02
CDR0000304669 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: June 6, 2003    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: March 2005

Keywords provided by National Cancer Institute (NCI):
recurrent gastric cancer
stage IV gastric cancer
adenocarcinoma of the stomach

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents