NCT00005938

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2000

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

April 20, 2004

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

5.1 years

First QC Date

July 5, 2000

Last Update Submit

May 15, 2012

Conditions

Extrahepatic Bile Duct CancerGallbladder CancerLiver Cancer

Keywords

localized gallbladder cancerunresectable gallbladder cancerrecurrent gallbladder cancerlocalized extrahepatic bile duct cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerliver and intrahepatic biliary tract cancercholangiocarcinoma of the gallbladdercholangiocarcinoma of the extrahepatic bile ductadult primary cholangiocellular carcinoma

Interventions

exatecan mesylateDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Cancer Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Bile Duct NeoplasmsGallbladder NeoplasmsLiver NeoplasmsCarcinoma, Hepatocellular

Interventions

exatecan

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Robert L. DeJager, MD, FACP

    Daiichi Sankyo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2000

First Posted

April 20, 2004

Study Start

March 1, 2000

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

US(5)