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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astex Pharmaceuticals; Astex Pharmaceuticals, Inc.
• Treatments: Gemcitabine; Rubitecan

Criteria

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.