RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of T900607 in treating patients who have
gastroesophageal junction cancer.
- Determine the response rate (complete and partial) in patients with previously treated
gastric or gastroesophageal junction carcinoma treated with T900607. (Gastric carcinoma
closed to accrual as of 02/04.)
- Determine the duration of response and time to disease progression in patients treated
with this drug.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the safety profile of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive T900607 IV over 1 hour once weekly. Treatment continues in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.
- Histologically or cytologically confirmed gastric or gastroesophageal junction
carcinoma (gastric carcinoma closed to accrual as of 02/04)
- Must have received 1 or 2 prior chemotherapy regimens for gastric carcinoma (gastric
carcinoma closed to accrual as of 02/04)
- Bidimensionally measurable disease
- At least 1 lesion that is at least 10 mm by CT scan
- No CNS metastases or carcinomatous meningitis
- 18 and over
- Karnofsky 70-100%
- At least 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3*
- Platelet count ≥ 100,000/mm^3*
- Hemoglobin ≥ 8.5 g/dL* NOTE: *Independent of growth factor or transfusion support
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN
- INR ≤ 1.5 (unless receiving anticoagulants)
- Albumin > 2.5 g/dL
- Creatinine ≤ 2 times ULN
- No New York Heart Association class III or IV heart disease
- LVEF ≥ 50%
- No acute anginal symptoms
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
- Able to comply with study procedures and follow-up
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix
- No severe infection
- No other concurrent severe medical condition or comorbidity that would preclude study
PRIOR CONCURRENT THERAPY:
- More than 7 days since prior growth factors or blood transfusions
- No concurrent therapeutic biological response modifier therapy
- No concurrent immunotherapy
- See Disease Characteristics
- No other concurrent cytotoxic chemotherapy
- No concurrent hormonal therapy
- No concurrent radiotherapy (including palliative radiotherapy)
- More than 4 weeks since prior major surgery
- More than 4 weeks since prior investigational agents
- No other concurrent investigational anticancer therapy