Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

T900607 in Treating Patients With Gastroesophageal Junction Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	CWRU-060214M TULA-T-607-006, TULA-TULI-1202, NCT00054249

Objectives

1. 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.)
2. Determine the duration of response and time to disease progression in patients treated with this drug.
3. Determine the pharmacokinetics of this drug in these patients.
4. Determine the safety profile of this drug in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³*
• Platelet count ≥ 100,000/mm³*
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Joanna Brell, MD, Protocol chair		Ph: 216-844-6031 Email: joanna.brell@case.edu

Registry Information
Official Title		A Phase II Study Of Intravenous T900607-Sodium In Subjects With Previously Treated Gastric Carcinoma
Trial Start Date		2002-09-04
Registered in ClinicalTrials.gov		NCT00054249
Date Submitted to PDQ		2002-12-23
Information Last Verified		2005-02-02
NCI Grant/Contract Number		P30-CA43703

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