Pancreatic Cancer
Conditions
Keywords
rubitecan, Orathecin, 9-nitrocamptothecin, gemcitabine, Gemzar, pancreatic cancer, adenocarcinoma, RFS 2000
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.
Interventions
DRUGRubitecan
Sponsors
Astex Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival | — |
Countries
United States
Outcome results
None listed