Expired Study
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Cleveland, Ohio 44106


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00054249


Primary Contact:

Study Chair
Joanna M. Brell, MD
Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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