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


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Joanna M. Brell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000269917

NCT ID:

NCT00054249

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Gastric Cancer
  • recurrent gastric cancer
  • Stomach Neoplasms

Name

Location

Ireland Cancer CenterCleveland, Ohio  44106-5065