- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00113256
Orathecin + Gemcitabine Versus Placebo + Gemcitabine in Chemonaive Non-Resectable Pancreatic Cancer
January 22, 2013 updated by: Astex Pharmaceuticals, Inc.
Randomized Trial of Orathecin and Gemcitabine Versus Placebo and Gemcitabine in Patients With Non-Resectable Pancreatic Cancer Who Have Not Already Received Chemotherapy
Patients will be treated with gemcitabine and Orathecin (rubitecan) capsules to evaluate the current estimate of overall survival as a study endpoint prior to launching the blinded randomized phase (versus gemcitabine and placebo) of the study.
Toxicity of the drug combination will also be evaluated.
Study Overview
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Corona, California, United States, 92882
- Compassionate Cancer Care Medical Group
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Fountain Valley, California, United States, 92708
- 11100 Warner Avenue, Ste. 200
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Soquel, California, United States, 95073
- The Cancer Research & Prevention Center
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Colorado
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Denver, Colorado, United States, 80210
- Mile High Oncology
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Kentucky
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Louisville, Kentucky, United States, 40202
- Norton Healthcare, Inc.
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Mary Bird Perkins Cancer Center
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Baton Rouge, Louisiana, United States, 70809
- Medical Oncology
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Mississippi
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Tupelo, Mississippi, United States, 38801
- N. Mississippi Hematology & Oncology Associates
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Missouri
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Kansas City, Missouri, United States, 64111
- Kansas City Cancer Center
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New York
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Great Neck, New York, United States, 11023
- Cancer Research of Long Island
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South Carolina
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Charleston, South Carolina, United States, 29403
- Charleston Hematology Oncology, PA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patient is at least 18 years of age.
- The patient has histologically or cytologically confirmed, non-resectable, Stage II-IV primary adenocarcinoma of the pancreas.
- The patient has had a baseline computed tomography (CT) scan, or magnetic resonance imaging (MRI), to evaluate tumor(s) within 28 days prior to randomization.
- The patient has never been treated with prior chemotherapy, with the exception of low-dose 5-fluorouracil (5-FU) as a radiation sensitizer.
- The patient has sufficiently recovered from the effects of previous surgery (no less than 3 weeks prior to randomization), radiotherapy, and/or immunotherapy (no less than 4 weeks prior to randomization).
- The patient's estimated life expectancy is at least 12 weeks.
- The patient has a Karnofsky Performance Status between 50 and 100.
- The patient has adequate bone marrow function.
- The patient has adequate hepatic and renal function.
Exclusion Criteria:
- The patient has any active, uncontrolled infection requiring antibiotics.
- The patient has any serious, uncontrolled concomitant systemic disorder.
- The patient has surgery scheduled within 8 weeks following initiation of treatment.
- The patient is pregnant or nursing.
- The patient is not capable of consistent oral intake of at least 3 L/day of fluid and/or requires constant intravenous (IV) hydration or frequent tube feeding.
- The patient is receiving any investigational agent(s) or has been a participant in a clinical trial within the last 30 days.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
survival
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
June 6, 2005
First Submitted That Met QC Criteria
June 6, 2005
First Posted (Estimate)
June 7, 2005
Study Record Updates
Last Update Posted (Estimate)
January 23, 2013
Last Update Submitted That Met QC Criteria
January 22, 2013
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Rubitecan
Other Study ID Numbers
- SGI-RUB-048
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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