NCT00113256

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Last Updated

August 2, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

June 6, 2005

Last Update Submit

August 1, 2024

Conditions

Pancreatic Cancer

Keywords

rubitecanOrathecin9-nitrocamptothecingemcitabineGemzarpancreatic canceradenocarcinomaRFS 2000

Outcome Measures

Primary Outcomes (1)

  • survival

Interventions

RubitecanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Compassionate Cancer Care Medical Group

Corona, California, 92882, United States

Location

11100 Warner Avenue, Ste. 200

Fountain Valley, California, 92708, United States

Location

The Cancer Research & Prevention Center

Soquel, California, 95073, United States

Location

Mile High Oncology

Denver, Colorado, 80210, United States

Location

Norton Healthcare, Inc.

Louisville, Kentucky, 40202, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Medical Oncology

Baton Rouge, Louisiana, 70809, United States

Location

N. Mississippi Hematology & Oncology Associates

Tupelo, Mississippi, 38801, United States

Location

Kansas City Cancer Center

Kansas City, Missouri, 64111, United States

Location

Cancer Research of Long Island

Great Neck, New York, 11023, United States

Location

Charleston Hematology Oncology, PA

Charleston, South Carolina, 29403, United States

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsAdenocarcinoma

Interventions

rubitecan

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2005

First Posted

June 7, 2005

Study Start

February 1, 2005

Primary Completion

February 1, 2006

Last Updated

August 2, 2024

Record last verified: 2024-08

Locations

US(11)