Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer

A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: irofulven

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Cancer Therapeutics Research Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Winnie Yeo, Prince of Wales Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: June 5, 2003
• First Submitted That Met QC Criteria: June 5, 2003
• First Posted (Estimate): June 6, 2003

Study Record Updates

• Last Update Posted (Estimate): May 15, 2013
• Last Update Submitted That Met QC Criteria: May 14, 2013
• Last Verified: March 1, 2005

More Information

Terms related to this study

• Keywords: stage IV gastric cancer; recurrent gastric cancer; adenocarcinoma of the stomach
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Irofulven
• Other Study ID Numbers: CTRG-G15/02; CDR0000304669 (Registry Identifier: PDQ (Physician Data Query)); NCI-6041