- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00062257
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
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
Phase
- Phase 2
Contacts and Locations
Study Locations
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New South Wales
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Sydney, New South Wales, Australia, 2050
- Sydney Cancer Centre at Royal Prince Alfred Hospital
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Shatin, New Territories, Hong Kong
- Prince Of Wales Hospital
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Seoul, Korea, Republic of, 120-752
- Yonsei Cancer Center at Yonsei University Medical Center
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Singapore, Singapore, 169610
- National Cancer Centre - Singapore
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Singapore, Singapore, 119074
- Cancer Institute at National University Hospital
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Singapore, Singapore, 119074
- Johns Hopkins - Singapore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Collaborators
Investigators
- Study Chair: Winnie Yeo, Prince Of Wales Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTRG-G15/02
- CDR0000304669 (Registry Identifier: PDQ (Physician Data Query))
- NCI-6041
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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