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A Phase II Study Of Intravenous T900607-Sodium In Subjects With Chemotherapy-Naive Unresectable Hepatocellular Carcinoma


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

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Trial Information

A Phase II Study Of Intravenous T900607-Sodium In Subjects With Chemotherapy-Naive Unresectable Hepatocellular Carcinoma


OBJECTIVES:

- Determine the complete and partial response rates of patients with chemotherapy-naïve
unresectable hepatocellular carcinoma treated with T900607.

- Determine the efficacy of this drug, in terms of duration of response and time to
disease progression, in these patients.

- Determine the pharmacokinetics of this drug in these patients.

- Determine the safety profile of this drug in these patients.

OUTLINE: This is a 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 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

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:

CDR0000270198

NCT ID:

NCT00054262

Start Date:

November 2002

Completion Date:

Related Keywords:

  • Liver Cancer
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Ireland Cancer CenterCleveland, Ohio  44106-5065