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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Trial of Orathecin and Gemcitabine Versus Placebo and Gemcitabine in Patients With Non-Resectable Pancreatic Cancer Who Have Not Already Received Chemotherapy

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Rubitecan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rubitecan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rubitecan, Orathecin, 9-nitrocamptothecin, gemcitabine, Gemzar, pancreatic cancer, adenocarcinoma, RFS 2000