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Orathecin + Gemcitabine Versus Placebo + Gemcitabine in Chemonaive Non-Resectable Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00113256
Recruitment Status : Terminated
First Posted : June 7, 2005
Last Update Posted : January 23, 2013
Information provided by (Responsible Party):
Astex Pharmaceuticals, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Rubitecan Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Orathecin and Gemcitabine Versus Placebo and Gemcitabine in Patients With Non-Resectable Pancreatic Cancer Who Have Not Already Received Chemotherapy
Study Start Date : February 2005
Actual Primary Completion Date : February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine

Primary Outcome Measures :
  1. survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00113256

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United States, California
Compassionate Cancer Care Medical Group
Corona, California, United States, 92882
11100 Warner Avenue, Ste. 200
Fountain Valley, California, United States, 92708
The Cancer Research & Prevention Center
Soquel, California, United States, 95073
United States, Colorado
Mile High Oncology
Denver, Colorado, United States, 80210
United States, Kentucky
Norton Healthcare, Inc.
Louisville, Kentucky, United States, 40202
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Medical Oncology
Baton Rouge, Louisiana, United States, 70809
United States, Mississippi
N. Mississippi Hematology & Oncology Associates
Tupelo, Mississippi, United States, 38801
United States, Missouri
Kansas City Cancer Center
Kansas City, Missouri, United States, 64111
United States, New York
Cancer Research of Long Island
Great Neck, New York, United States, 11023
United States, South Carolina
Charleston Hematology Oncology, PA
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Astex Pharmaceuticals, Inc.

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Responsible Party: Astex Pharmaceuticals, Inc. Identifier: NCT00113256    
Other Study ID Numbers: SGI-RUB-048
First Posted: June 7, 2005    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: October 2009
Keywords provided by Astex Pharmaceuticals, Inc.:
pancreatic cancer
RFS 2000
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors