Gemcitabine, Oxaliplatin and Radiation Therapy in Pancrea... | NCT00242190

Studies
Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer

NCT00242190

Sponsor

University of Michigan Rogel Cancer Center

Status

Completed

Last Update Posted

Nov 15, 2010Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Pancreatic Neoplasms

Interventions

oxaliplatin
gemcitabine
radiation therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Mar 2006Actual

Completion Date

Feb 2010Actual

First Submitted Date

Oct 18, 2005

First Submission Date that Met QC Criteria

Oct 18, 2005

First Posted Date

Oct 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2010

Last Update Posted Date

Nov 15, 2010Estimated

Name	Class
Sanofi-Synthelabo	INDUSTRY

Description Module

Brief Summary

This study will examine a proposed research treatment which evaluates the addition of oxaliplatin, a chemotherapy agent, to gemcitabine, another chemotherapy agent, and radiation therapy for the treatment of patients with pancreatic cancer. The researchers have already done studies using gemcitabine and radiation therapy together. They want to build on the information they have from this previous research. The researchers believe that the combination chemotherapy with radiation is worth investigating to treat pancreatic cancer. They will use this study to determine what type of side effects occur with this treatment and to assess how effective the treatment is at controlling the cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
Occurrence of dose limiting toxicity up to three weeks following the second cycle of chemotherapy.

Measure	Description	Time Frame
Characterize pattern of responses, progression free survival, and survival after treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
Patients may have any stage of pancreatic cancer but if metastatic, systemic disease burden should be asymptomatic and small in volume.
Determination of resectability must be made prior to registration.
Patients must have an estimated life expectancy of at least 12 weeks and a Zubrod performance status of < = 2.
Patients must have adequate organ function defined as follows: absolute neutrophil count of > = 1500/mm3, platelets > = 100,000/mm3, serum Cr < = 1.5 mg/dl, bilirubin < 3.0 mg/dl, with relief of biliary obstruction if present (PTC tube or endobiliary stent).
Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
Patients of reproductive potential must have agreed to use an effective contraceptive method during participation in this trial and for 6 months after trial.
Patient must be aware of the investigational nature of the therapy and provide written informed consent.

Exclusion Criteria:

Patients with neuroendocrine tumors are excluded.
Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
Patient must not have used any investigational agent in the month before enrollment into the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

ID	Term
D000077150	Oxaliplatin
D000093542	Gemcitabine
D011878	Radiotherapy

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D006571	Heterocyclic Compounds
D003841	Deoxycytidine

Name	Type	Description	Arm Group Labels	Other Names
oxaliplatin	Drug
gemcitabine	Drug
radiation therapy	Procedure