T900607 in Treating Patients With Gastroesophageal Junction Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054249
First received: February 5, 2003
Last updated: July 17, 2013
Last verified: September 2010
  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.


Condition Intervention Phase
Gastric Cancer
Drug: T900607
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Intravenous T900607-Sodium In Subjects With Previously Treated Gastric Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2002
Study Completion Date: September 2010
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
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.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054249

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-1714
Sponsors and Collaborators
University Hospitals Seidman Cancer Center
Investigators
Study Chair: Joanna M. Brell, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00054249     History of Changes
Other Study ID Numbers: TULA-T-607-006, CWRU-060214M, CDR0000269917, TULA-TULI-1202
Study First Received: February 5, 2003
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on April 17, 2014