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

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: Rubitecan

SGI-RUB-048

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-06-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-08-01
First Submitted that Met QC Criteria 2005-06-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-08-02
First Posted (ACTUAL) 2005-06-07	Results First Posted N/A	Last Verified 2024-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
survival

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record