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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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New South Wales
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Sydney, New South Wales, Australien, 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, Republikken, 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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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Winnie Yeo, Prince of Wales Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Mavesygdomme
- Neoplasmer i maven
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Irofulven
Andre undersøgelses-id-numre
- CTRG-G15/02
- CDR0000304669 (Registry Identifier: PDQ (Physician Data Query))
- NCI-6041
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