T900607 in Treating Patients With Gastroesophageal Junction Cancer

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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