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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00113256
• Other study ID #: SGI-RUB-048
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: June 6, 2005
• Last updated: January 22, 2013
• Start date: February 2005

Study information

• Verified date: October 2009
• Source: Astex Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Rubitecan

Locations

Country	Name	City	State
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	Medical Oncology	Baton Rouge	Louisiana
United States	Charleston Hematology Oncology, PA	Charleston	South Carolina
United States	Compassionate Cancer Care Medical Group	Corona	California
United States	Mile High Oncology	Denver	Colorado
United States	11100 Warner Avenue, Ste. 200	Fountain Valley	California
United States	Cancer Research of Long Island	Great Neck	New York
United States	Kansas City Cancer Center	Kansas City	Missouri
United States	Norton Healthcare, Inc.	Louisville	Kentucky
United States	The Cancer Research & Prevention Center	Soquel	California
United States	N. Mississippi Hematology & Oncology Associates	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Astex Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival