Title
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
Phase
Phase 2Lead Sponsor
Cancer Therapeutics Research GroupStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Gastric CancerIntervention/Treatment
mgi-114 ...Study Participants
NoneRATIONALE: 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.
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.
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
