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Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Active 18 and over Pharmaceutical / Industry SGI-RUB-048 NCT00113256

Trial Description

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

SuperGen, Incorporated

Jocelyn Rojas, RN

Ph: 925-560-0100 Ext.424

Mag Sohal

Ph: 925-560-0100 Ext.416

U.S.A.
California
	Corona
	Compassionate Cancer Care Medical Group Incorporated - Corona
		Yudhishtra Markan, MD	Principal Investigator
	Fountain Valley
	11100 Warner Avenue, Ste. 200
		Robert Moss, MD	Principal Investigator
	Soquel
	Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital
		J. Talisman Pomeroy, MD	Principal Investigator
Colorado
	Denver
	Mile High Oncology
		David Schrier, MD	Principal Investigator
Kentucky
	Louisville
	Louisville Oncology at Norton Cancer Institute - Louisville
		John T. Hamm, MD	Principal Investigator
Louisiana
	Baton Rouge
	Mary Bird Perkins Cancer Center - Baton Rouge
		Judd E. Patten, MD, PhD	Principal Investigator
	Medical Oncology, LLC
		Michael Castine, MD	Principal Investigator
Mississippi
	Tupelo
	North Mississippi Hematology and Oncology Associates, Limited
		Christopher Croot, MD	Principal Investigator
Missouri
	Kansas City
	Kansas City Cancer Centers - Central
		Robert J. Belt, MD	Principal Investigator
New York
	Great Neck
	Cancer Institute of Long Island
		Hal Gerstein	Principal Investigator
South Carolina
	Charleston
	Charleston Hematology Oncology Associates, PA
		David Michael Ellison	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00113256
Information obtained from ClinicalTrials.gov on May 27, 2008