T900607 in Treating Patients With Gastroesophageal Junction Cancer

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

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.

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.

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