T900607 in Treating Patients With Gastroesophageal Junction Cancer

Gastric Cancer Clinical Trial

Official title:

A Phase II Study Of Intravenous T900607-Sodium In Subjects With Previously Treated Gastric Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054249
• Other study ID #: TULA-T-607-006
• Secondary ID: CWRU-060214MCDR0
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2003
• Last updated: July 17, 2013
• Start date: September 2002
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• T900607

Locations

Country	Name	City	State
United States	Ireland Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Seidman Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,