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DX-8951f in Treating Patients With Biliary Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about DX-8951f in Treating Patients With Biliary Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. DX-8951f in Treating Patients With Biliary Cancer Clinical research trials and DX-8951f in Treating Patients With Biliary Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as DX-8951f in Treating Patients With Biliary Cancer. DX-8951f in Treating Patients With Biliary Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a DX-8951f in Treating Patients With Biliary Cancer clinical trial. Subjects often receive the most expert healthcare possible for their DX-8951f in Treating Patients With Biliary Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > DX-8951f in Treating Patients With Biliary Cancer  DX-8951f in Treating Patients With Biliary Cancer
DX-8951f in Treating Patients With Biliary Cancer
For Condition: cholangiocarcinoma of the gallbladder,adult primary cholangiocellular carcinoma,recurrent gallbladder cancer,localized gallbladder cancer,unresectable extrahepatic bile duct cancer,liver and intrahepatic biliary tract cancer,unresectable gallbladder cancer,cholangiocarcinoma of the extrahepatic bile duct,recurrent extrahepatic bile duct cancer,localized extrahepatic bile duct cancer
Status: No longer recruiting
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertDeJager, Study Chair, Daiichi Pharmaceuticals
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Cancer Therapy & Research Center
San Antonio, Texas, 78229
United States
Additional Information:
Study ID Numbers: CDR0000067736; MSKCC-99110,UTHSC-9905011256,DAIICHI-8951A-PRT020,SACI-IDD-99-31,MDA-ID-99379,UCHSC-00892
Study Start Date: March 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005938
Other Cholangiocarcinoma Of The Gallbladder Studies:
1. DX-8951f in Treating Patients With Biliary Cancer
2. Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
3. Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
4. 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer
Related Studies:
Other cholangiocarcinoma of the gallbladder Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
DX-8951f in Treating Patients With Biliary Cancer
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