Know Cancer

forgot password

A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hepatocellular Carcinoma

Phase 2
16 Years
Not Enrolling
Liver Cancer

Thank you

Trial Information

A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hepatocellular Carcinoma

OBJECTIVES: I. Evaluate the antitumor activity of DX-8951f in terms of antitumor response,
response duration, and survival in patients with hepatocellular carcinoma. II. Assess the
quantitative and qualitative toxicities of this treatment regimen in this patient
population. III. Evaluate the pharmacokinetics of DX-8951 in plasma.

OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment repeats
every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable
toxicity. Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 12 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed hepatocellular carcinoma with or without
evidence of unresectable extrahepatic metastasis Previously untreated disease OR
Progressive disease after first line chemotherapy Bidimensionally measurable disease by CT
scan, chest x-ray, or MRI of the abdomen No brain metastases

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 80,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2.0
mg/dL Albumin at least 2.8 g/dL SGOT/SGPT no greater than 5 times upper limit of normal
(ULN) PT/INR no greater than 1.5 times ULN if not on coumadin therapy Renal: Creatinine no
greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled
angina No myocardial infarction within the past 6 months Other: No concurrent serious
infection No other life threatening illness No overt psychosis or mental disability that
would preclude informed consent No other malignancy within the past 5 years except
curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception 1 month prior to and during the study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy:
See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No
prior camptothecin analogues No other concurrent chemotherapy Endocrine therapy: Not
specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No
concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered
No concurrent surgery Other: No other concurrent anticancer therapy At least 4 weeks since
prior investigational drugs (including analgesics or antiemetics) No other investigational
drugs during or within 28 days after final dose of study drug

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert L. DeJager, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Sankyo Inc.


United States: Federal Government

Study ID:




Start Date:

September 1999

Completion Date:

April 2005

Related Keywords:

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



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Colorado Cancer Center Denver, Colorado  80262
Cancer Therapy & Research Center San Antonio, Texas  78229