Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer

Summary: 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.

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.

Eligibility: 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

Relevance to patient case: not relevant