Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: June 5, 2003
Last updated: May 14, 2013
Last verified: March 2005

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 Intervention Phase
Gastric Cancer
Drug: irofulven
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2003
Study Completion Date: September 2006
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00062257

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
Study Chair: Winnie Yeo Prince of Wales Hospital
  More Information

No publications provided Identifier: NCT00062257     History of Changes
Other Study ID Numbers: CTRG-G15/02, CDR0000304669, NCI-6041
Study First Received: June 5, 2003
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Stomach Diseases
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on November 20, 2014