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T900607 in Treating Patients With Gastroesophageal Junction Cancer
This study is ongoing, but not recruiting participants.
Study NCT00054249   Information provided by National Cancer Institute (NCI)
First Received: February 5, 2003   Last Updated: July 23, 2008   History of Changes

February 5, 2003
July 23, 2008
September 2002
 
 
 
Complete list of historical versions of study NCT00054249 on ClinicalTrials.gov Archive Site
 
 
 
T900607 in Treating Patients With Gastroesophageal Junction Cancer
A Phase II Study Of Intravenous T900607-Sodium In Subjects With Previously Treated Gastric Carcinoma

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.

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.

Phase II
Interventional
Treatment, Open Label
Gastric Cancer
Drug: T900607
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00054249
 
CDR0000269917, CWRU-060214M, TULA-T-607-006, TULA-TULI-1202
Ireland Cancer Center
National Cancer Institute (NCI)
Study Chair: Joanna M. Brell, MD Case Comprehensive Cancer Center
National Cancer Institute (NCI)
February 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP