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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

survival

Authority:

United States: Food and Drug Administration

Study ID:

SGI-RUB-048

NCT ID:

NCT00113256

Start Date:

February 2005

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • rubitecan
  • Orathecin
  • 9-nitrocamptothecin
  • gemcitabine
  • Gemzar
  • pancreatic cancer
  • adenocarcinoma
  • RFS 2000
  • Pancreatic Neoplasms

Name

Location

Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Norton Healthcare, Inc.Louisville, Kentucky  40202
Kansas City Cancer CenterKansas City, Missouri  64111
Mile High OncologyDenver, Colorado  80210
Cancer Research of Long IslandGreat Neck, New York  11023
Charleston Hematology Oncology, PACharleston, South Carolina  29403
Compassionate Cancer Care Medical GroupCorona, California  92882
11100 Warner Avenue, Ste. 200Fountain Valley, California  92708
The Cancer Research & Prevention CenterSoquel, California  95073
Medical OncologyBaton Rouge, Louisiana  70809
N. Mississippi Hematology & Oncology AssociatesTupelo, Mississippi  38801