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3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer Clinical research trials and 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer. 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "3" Clinical Trials Conditions > 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer  3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer
3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer
For Condition: unresectable extrahepatic bile duct cancer,unresectable gallbladder cancer,recurrent extrahepatic bile duct cancer,recurrent gallbladder cancer,adenocarcinoma of the extrahepatic bile duct
Status: Recruiting
Sponsor(s): Cornell University Medical College , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more cancer cells by making them more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining 3-AP with gemcitabine in treating patients who have unresectable or metastaticbile duct or gallbladder cancer.
Details: OBJECTIVES: - Determine the objective response rate in patients with unresectable or metastatic biliary duct or gallbladder cancer treated with 3-AP (Triapine®) and gemcitabine. - Determine the toxic effects and recovery from toxic effects of this regimen in these patients. - Determine the survival and progression-free survival of patients treated with this regimen. OUTLINE: This is a non-randomized, multicenter study. Patients are stratified according to bilirubin levels (normal vs abnormal). Patients receive 3-AP (Triapine®) IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 1 additional course beyond CR. Patients are followed for up to 2 years. PROJECTED ACCRUAL: A total of 31-78 patients (10-29 with liver dysfunction and 21-49 without liver dysfunction) will be accrued for this study within 10-25 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed diagnosis of 1 of the following: - Adenocarcinoma of the biliary duct - Carcinoma of the ampulla of Vater - Gallbladder cancer - Unresectable or metastatic disease - Measurable disease - At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No glucose-6-phosphate dehydrogenase deficiency Hepatic - Bilirubin no greater than 3 times upper limit of normal Renal - Creatinine normal Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary - No uncontrolled pulmonary disease, including any of the following: - Asthma - Chronic bronchitis - Chronic obstructive pulmonary disease - No requirement for chronic oxygen use Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs - No ongoing or active infection - No other concurrent uncontrolled illness - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for the malignancy Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy and recovered Surgery - At least 4 weeks since prior definitive surgery and recovered - Recovered from prior surgical biopsy Other - No other concurrent investigational agents - No other concurrent anticancer therapy - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottWadler, Principal Investigator, Cornell University Medical College
CCOP - North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Vincent Vinciguerra 516-562-8915
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10467
United States
Recruiting Andreas Kaubisch 718-920-4826
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Robert Fine 212-305-1168
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler 212-746-2844
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Jonathan Schwartz 212-241-3984
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Yun Yen 626-359-8111
Additional Information:
Study ID Numbers: CDR0000346767; NYWCCC-NCI-6254,NCI-6254
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075504
Other Recurrent Gallbladder Cancer Studies:
1. 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer
2. Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
3. DX-8951f in Treating Patients With Biliary Cancer
4. Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
Related Studies:
Other recurrent gallbladder cancer Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer
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