Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: BMS-247550 in Treating Patients With Metastatic Stomach Cancer Previously Treated With Chemotherapy

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have metastatic stomach cancer previously treated with chemotherapy.

Detailed description: OBJECTIVES:
  -  Determine the clinical activity of BMS-247550, in terms of response rate, in patients with previously treated metastatic gastric adenocarcinoma.
  -  Determine the safety of this drug in these patients.
  -  Assess the response duration, time to progression, and survival of patients treated with this drug.
  OUTLINE: This is a multicenter study.
  Patients receive BMS-247550 IV over 1 hour on day 1. Treatment repeats every 21 days for 2-18 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses after confirmation of CR.
  Patients are followed every 3 months.
  PROJECTED ACCRUAL: A total of 21-58 patients will be accrued for this study within 1 year.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed adenocarcinoma originating in the stomach or gastroesophageal junction
  -  Failed prior taxane-based chemotherapy regimen* in the metastatic setting OR
  -  Relapsed within 6 months of completing taxane-based chemotherapy* in the adjuvant setting
  -  Bidimensionally measurable metastatic disease
  -  No prior radiotherapy to only measurable target lesion
  -  No squamous cell or sarcomatous disease
  -  No known brain metastases NOTE: *Regimen must have included a fluopyrimidine and/or a platinum drug
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  At least 12 weeks
  Hematopoietic:
  -  Absolute neutrophil count at least 2,000/mm^3
  -  Platelet count greater than 125,000/mm^3
  Hepatic:
  -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  -  ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
  Renal:
  -  Creatinine no greater than 2 times ULN
  Cardiovascular:
  -  No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months
  Other:
  -  No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  -  No serious concurrent infection
  -  No nonmalignant uncontrolled medical illness that would preclude study
  -  No psychiatric disorder or other condition that would preclude study compliance
  -  No neuropathy (neuromotor or neurosensory) of grade 2 or greater
  -  No known severe hypersensitivity to agents containing Cremophor EL
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception during and for 2 months after the study
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No concurrent immunotherapy
  Chemotherapy:
  -  See Disease Characteristics
  -  At least 3 weeks since prior chemotherapy for metastatic disease
  -  Prior neoadjuvant and adjuvant chemotherapy allowed
  -  No more than 1 prior chemotherapy regimen for metastatic disease
  -  No other concurrent chemotherapy
  Endocrine therapy:
  -  No concurrent hormonal therapy except hormone replacement therapy
  Radiotherapy:
  -  See Disease Characteristics
  -  At least 3 weeks since prior radiotherapy and recovered
  -  No prior radiotherapy to major bone marrow-containing areas (e.g., pelvis or lumbar spine)
  -  No concurrent therapeutic radiotherapy
  Surgery:
  -  At least 1 week since prior minor surgery and recovered
  -  At least 3 weeks since prior major surgery and recovered
  Other:
  -  No other concurrent experimental anticancer medications

Relevance to patient case: not relevant