Gastric Cancer
Conditions
Keywords
recurrent gastric cancer
Brief summary
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.
Detailed description
OBJECTIVES: * 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.
Interventions
DRUGT900607
Sponsors
National Cancer Institute (NCI)
University Hospitals Seidman Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * At least 12 weeks Hematopoietic * 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 Hepatic * 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 Renal * Creatinine ≤ 2 times ULN Cardiovascular * No New York Heart Association class III or IV heart disease * LVEF ≥ 50% * No acute anginal symptoms Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * 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 participation PRIOR CONCURRENT THERAPY: Biologic therapy * More than 7 days since prior growth factors or blood transfusions * No concurrent therapeutic biological response modifier therapy * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * No other concurrent cytotoxic chemotherapy Endocrine therapy * No concurrent hormonal therapy Radiotherapy * No concurrent radiotherapy (including palliative radiotherapy) Surgery * More than 4 weeks since prior major surgery Other * More than 4 weeks since prior investigational agents * No other concurrent investigational anticancer therapy
Countries
United States
Outcome results
None listed