A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer

Inclusion 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