T900607 in Treating Patients With Gastroesophageal Junction Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study Of Intravenous T900607-Sodium In Subjects With Previously Treated Gastric Carcinoma

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: T900607


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: T900607|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent gastric cancer