NCT00054249CompletedPhase 2
A Phase II Study Of Intravenous T900607-Sodium In Subjects With Previously Treated Gastric Carcinoma
University Hospitals Seidman Cancer Center2 sites in 1 countryStarted: September 1, 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Locations
- 2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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:
- •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
- •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
- •Cardiovascular
- •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 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)
- •More than 4 weeks since prior major surgery
- •More than 4 weeks since prior investigational agents
- •No other concurrent investigational anticancer therapy
Exclusion Criteria
- Not provided
Investigators
Study Sites (2)
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