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Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
irofulven
Sponsored by
Cancer Therapeutics Research Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring recurrent gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sydney Cancer Centre at Royal Prince Alfred Hospital
  • Prince of Wales Hospital
  • Yonsei Cancer Center at Yonsei University Medical Center
  • Cancer Institute at National University Hospital
  • Johns Hopkins - Singapore
  • National Cancer Centre - Singapore

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 5, 2003
Last Updated
May 14, 2013
Sponsor
Cancer Therapeutics Research Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00062257
Brief Title
Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer
Official Title
A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Therapeutics Research Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
recurrent gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irofulven

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winnie Yeo
Organizational Affiliation
Prince of Wales Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sydney Cancer Centre at Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Prince of Wales Hospital
City
Shatin, New Territories
Country
Hong Kong
Facility Name
Yonsei Cancer Center at Yonsei University Medical Center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Cancer Institute at National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Johns Hopkins - Singapore
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Cancer Centre - Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore

12. IPD Sharing Statement

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Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer

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