Status:
TERMINATED
Orathecin + Gemcitabine Versus Placebo + Gemcitabine in Chemonaive Non-Resectable Pancreatic Cancer
Lead Sponsor:
Astex Pharmaceuticals, Inc.
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 (v...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00113256
Start Date
February 1 2005
Last Update
August 2 2024
Active Locations (11)
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1
Compassionate Cancer Care Medical Group
Corona, California, United States, 92882
2
11100 Warner Avenue, Ste. 200
Fountain Valley, California, United States, 92708
3
The Cancer Research & Prevention Center
Soquel, California, United States, 95073
4
Mile High Oncology
Denver, Colorado, United States, 80210