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Orathecin + Gemcitabine Versus Placebo + Gemcitabine in Chemonaive Non-Resectable Pancreatic Cancer
This study is currently recruiting participants.
Verified by SuperGen, June 2005
First Received: June 6, 2005   Last Updated: February 7, 2007   History of Changes
Sponsored by: SuperGen
Information provided by: SuperGen
ClinicalTrials.gov Identifier: NCT00113256
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: Rubitecan
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by SuperGen:

Primary Outcome Measures:
  • survival

Estimated Enrollment: 30
Study Start Date: February 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113256

Contacts
Contact: Jocelyn Rojas, RN 925-560-0100 ext 424
Contact: Mag Sohal 925-560-0100 ext 416

Locations
United States, California
11100 Warner Avenue, Ste. 200 Recruiting
Fountain Valley, California, United States, 92708
Principal Investigator: Robert Moss, MD            
The Cancer Research & Prevention Center Recruiting
Soquel, California, United States, 95073
Principal Investigator: J. Talisman Pomeroy, MD            
Compassionate Cancer Care Medical Group Recruiting
Corona, California, United States, 92882
Principal Investigator: Yudhishtra Markan, MD            
United States, Colorado
Mile High Oncology Recruiting
Denver, Colorado, United States, 80210
Principal Investigator: David Schrier, MD            
United States, Kentucky
Norton Healthcare, Inc. Recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: John T. Hamm, MD            
United States, Louisiana
Medical Oncology Recruiting
Baton Rouge, Louisiana, United States, 70809
Principal Investigator: Michael Castine, MD            
Mary Bird Perkins Cancer Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Principal Investigator: Judd E. Patten, MD, PhD            
United States, Mississippi
N. Mississippi Hematology & Oncology Associates Recruiting
Tupelo, Mississippi, United States, 38801
Principal Investigator: Christopher Croot, MD            
United States, Missouri
Kansas City Cancer Center Recruiting
Kansas City, Missouri, United States, 64111
Principal Investigator: Robert J. Belt, MD            
United States, New York
Cancer Research of Long Island Recruiting
Great Neck, New York, United States, 11023
Principal Investigator: Hal Gerstein, MD            
United States, South Carolina
Charleston Hematology Oncology, PA Recruiting
Charleston, South Carolina, United States, 29403
Principal Investigator: David Ellison, MD            
Sponsors and Collaborators
SuperGen
  More Information

No publications provided

Study ID Numbers: SGI-RUB-048
Study First Received: June 6, 2005
Last Updated: February 7, 2007
ClinicalTrials.gov Identifier: NCT00113256     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by SuperGen:
rubitecan
Orathecin
9-nitrocamptothecin
gemcitabine
Gemzar
pancreatic cancer
adenocarcinoma
RFS 2000

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
9-nitrocamptothecin
Immunosuppressive Agents
Antiviral Agents
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors
9-nitrocamptothecin
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on August 30, 2009