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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 02, 2014