T900607 in Treating Patients With Unresectable Liver Cancer

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

Summary

RATIONALE: Drugs used in chemotherapy use 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 unresectable liver 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 unresectable hepatocellular carcinoma (HCC)

• Bidimensionally measurable disease defined as at least 1 lesion that is 1 cm or more in 2 dimensions by CT scan

• Class A or B Child-Pugh liver classification

• No prior 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 at least 1,500/mm^3*

• Platelet count at least 100,000/mm^3*

• Hemoglobin at least 8.5 g/dL* NOTE: *More than 7 days since prior blood transfusions or growth factors

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• Albumin greater than 2.5 g/dL

• AST and ALT no greater than 3 times ULN

• INR no greater than 1.5 (unless receiving anticoagulants)

Renal

• Creatinine no greater than 2 times ULN

Cardiovascular

• LVEF at least 50%

• No New York Heart Association class III or IV cardiac disease

• 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

• No severe concurrent disease, infection, or co-morbidity that would preclude study entry

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior immunotherapy for HCC

• No concurrent therapeutic biological response modifier

Chemotherapy

• No prior chemotherapy for HCC

• No prior chemoembolization for HCC

• No other concurrent cytotoxic chemotherapy

Endocrine therapy

• At least 6 weeks since prior hormonal therapy (an indicator lesion must exist outside the area of therapy

• No concurrent hormonal anticancer therapy

Radiotherapy

• No prior radiotherapy for HCC

• At least 6 weeks since prior radiofrequency ablation, selective internal radiation, or embolization (an indicator lesion must exist outside the area of therapy)

• No concurrent radiotherapy (including palliative therapy)

Surgery

• At least 6 weeks since prior surgical resection (an indicator lesion must exist outside the area of therapy)

• Recurrence at the margin of the surgical resection is allowed

• At least 6 weeks since prior cryosurgery

• More than 4 weeks since other prior major surgery

Other

• More than 4 weeks since prior investigational therapy

• At least 6 weeks since prior intratumoral ethanol injection (an indicator lesion must exist outside the area of therapy)

• No other concurrent investigational anticancer therapy