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DX-8951f in Treating Patients With Biliary Cancer
This study is ongoing, but not recruiting participants.
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes
Sponsored by: Daiichi Sankyo Inc.
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005938
  Purpose

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 DX-8951f in treating patients who have biliary cancer.


Condition Intervention Phase
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Liver Cancer
Drug: exatecan mesylate
Phase II

MedlinePlus related topics: Cancer Gallbladder Cancer Liver Cancer
Drug Information available for: Exatecan Exatecan mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: 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)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2000
Detailed Description:

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 months.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005938

Locations
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
Cancer Therapy & Research Center
San Antonio, Texas, United States, 78229
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
Study Chair: Robert L. DeJager, MD, FACP Daiichi Sankyo Inc.
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067736, DAIICHI-8951A-PRT020, MDA-ID-99379, MSKCC-99110, SACI-IDD-99-31, UCHSC-00892, UTHSC-9905011256
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005938     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Gallbladder Diseases
Cholangiocarcinoma
Liver Diseases
Biliary Tract Neoplasms
Digestive System Neoplasms
DX 8951
Bile Duct Cancer, Extrahepatic
Recurrence
Carcinoma
Liver Neoplasms
Gall Bladder Cancer
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Gastrointestinal Neoplasms
Biliary Tract Cancer
Gallbladder Neoplasms
Bile Duct Neoplasms
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Gallbladder Diseases
Cholangiocarcinoma
Liver Diseases
Neoplasms by Histologic Type
Biliary Tract Neoplasms
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
DX 8951
Pharmacologic Actions
Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Bile Duct Diseases
Therapeutic Uses
Biliary Tract Diseases
Gallbladder Neoplasms
Bile Duct Neoplasms
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009