search
Back to results

T900607 in Treating Patients With Gastroesophageal Junction Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
T900607
Sponsored by
University Hospitals Seidman Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring recurrent gastric cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ireland Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
July 17, 2013
Sponsor
University Hospitals Seidman Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00054249
Brief Title
T900607 in Treating Patients With Gastroesophageal Junction Cancer
Official Title
A Phase II Study Of Intravenous T900607-Sodium In Subjects With Previously Treated Gastric Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospitals Seidman Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
recurrent gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
T900607

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna M. Brell, MD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1714
Country
United States

12. IPD Sharing Statement

Learn more about this trial

T900607 in Treating Patients With Gastroesophageal Junction Cancer

We'll reach out to this number within 24 hrs