Clinical trial NCT00113256: Orathecin + Gemcitabine Versus Placebo + Gemcitabine in Chemonaive Non-Resectable Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Pancreatic Cancer
Keywords: rubitecan
Orathecin
9-nitrocamptothecin
gemcitabine
Gemzar
pancreatic cancer
adenocarcinoma
RFS 2000
Lead sponsor: Astex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2005-06-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: survival
Secondary outcomes:
Other outcomes:
Locations:
city: Corona
country: United States
facility: Compassionate Cancer Care Medical Group
state: California
city: Fountain Valley
country: United States
facility: 11100 Warner Avenue, Ste. 200
state: California
city: Soquel
country: United States
facility: The Cancer Research & Prevention Center
state: California
city: Denver
country: United States
facility: Mile High Oncology
state: Colorado
city: Louisville
country: United States
facility: Norton Healthcare, Inc.
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Medical Oncology
state: Louisiana
city: Tupelo
country: United States
facility: N. Mississippi Hematology & Oncology Associates
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City Cancer Center
state: Missouri
city: Great Neck
country: United States
facility: Cancer Research of Long Island
state: New York
city: Charleston
country: United States
facility: Charleston Hematology Oncology, PA
state: South Carolina
Study officials:
References: