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

Phase 2

Terminated

• Conditions: Pancreatic Cancer

• Registration Number: NCT00113256
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-06-06
• Study First Submitted QC: 2005-06-06
• Study First Posted: 2005-06-07
• Primary Completion: 2006-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
survival

Trial Locations

Locations (11)

Mary Bird Perkins Cancer Center; 🇺🇸 Baton Rouge, Louisiana, United States

Medical Oncology; 🇺🇸 Baton Rouge, Louisiana, United States

N. Mississippi Hematology & Oncology Associates; 🇺🇸 Tupelo, Mississippi, United States

Compassionate Cancer Care Medical Group; 🇺🇸 Corona, California, United States

11100 Warner Avenue, Ste. 200; 🇺🇸 Fountain Valley, California, United States

The Cancer Research & Prevention Center; 🇺🇸 Soquel, California, United States

Cancer Research of Long Island; 🇺🇸 Great Neck, New York, United States

Mile High Oncology; 🇺🇸 Denver, Colorado, United States

Charleston Hematology Oncology, PA; 🇺🇸 Charleston, South Carolina, United States

Norton Healthcare, Inc.; 🇺🇸 Louisville, Kentucky, United States

Kansas City Cancer Center; 🇺🇸 Kansas City, Missouri, United States