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A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Biliary Tree Cancer (Cholangiocarcinoma and Gallbladder Cancer)

Phase 2
16 Years
Not Enrolling
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, 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 Biliary Tree Cancer (Cholangiocarcinoma and Gallbladder Cancer)

OBJECTIVES: I. Determine the antitumor activity of DX-8951f in terms of antitumor response,
response duration, and survival in patients with biliary tree cancer. II. Evaluate 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 within 12

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed cholangiocarcinoma, bile duct cancer, or
gallbladder cancer 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 known
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 100,000/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 or SGPT no greater than 5 times upper limit of normal
(ULN) PT or 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: Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception
before and during study 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
Carcinoma in situ of the cervix

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 No other investigational drugs during or within 4 weeks after
final dose of study drug No concurrent drugs that induce or inhibit CYP3A enzyme

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:

March 2000

Completion Date:

April 2005

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • localized gallbladder cancer
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • localized extrahepatic bile duct cancer
  • unresectable extrahepatic bile duct cancer
  • recurrent extrahepatic bile duct cancer
  • liver and intrahepatic biliary tract cancer
  • cholangiocarcinoma of the gallbladder
  • cholangiocarcinoma of the extrahepatic bile duct
  • adult primary cholangiocellular carcinoma
  • Liver Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Cholangiocarcinoma



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