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

Stopped early · Phase 2/Phase 3

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00113256

Run by

Astex Pharmaceuticals, Inc.

People needed

39

Starts

2005-02-01

Last updated by the study team

2024-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Mile High Oncology — Denver, Colorado, United States
• Norton Healthcare, Inc. — Louisville, Kentucky, United States
• 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
• Kansas City Cancer Center — Kansas City, Missouri, United States
• Cancer Research of Long Island — Great Neck, New York, United States
• Charleston Hematology Oncology, PA — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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