Clinical trial NCT00062257 (phase 2, status: completed)
Conditions: gastric cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: irofulven
SMILES: CC1=C(CO)C2=C(C)C3(CC3)[C@@](C)(O)C(=O)C2=C1
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