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Clinical Trials/NCT00054249
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

Sponsor
University Hospitals Seidman Cancer Center
Sponsor Class
Other

Study Sites (2)

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