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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Astex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00113256
First received: June 6, 2005
Last updated: January 22, 2013
Last verified: October 2009
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astex Pharmaceuticals:

Primary Outcome Measures:
  • survival

Enrollment: 39
Study Start Date: February 2005
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
  More Information

No publications provided

Responsible Party: Astex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00113256     History of Changes
Other Study ID Numbers: SGI-RUB-048
Study First Received: June 6, 2005
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014