Weekly Dosing Of An Integrative Chemotherapy Combination To Treat Advanced Pancreatic Cancer

Study Overview

Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, oxaliplatin, leucovorin and 5-fluoruracil, work in different ways separately and in combination to stop tumor cells from dividing so they stop growing or die. The use of metronomic dosing of chemotherapy minimizes side effects and increases efficacy by anti-angiogenic effects. The pilot study demonstrated promising responses in all patients. It is not yet known how effective this drug and dosing combination is in treating advanced pancreatic cancer. PURPOSE: This non-randomized phase II trial is studying giving weekly doses of paclitaxel, oxaliplatin, leucovorin and 5-fluorouracil together as second or third-line therapy in treating patient with locally advanced unresectable or metastatic adenocarcinoma of the pancreas following demonstrated progression after first-line gemcitabine.

OBJECTIVES: * The primary objective is to determine the effectiveness the chemotherapy combination in improving the experience of those with advanced pancreatic cancer in * Pain control and other aspects of quality of life * Reduction of the tumor size or stabilization of tumor growth * Progression free survival * Overall survival * The secondary objective is to determine the safety of this chemotherapy combination by monitoring and the managing the potential side effects DOSE REGIMEN OUTLINE: Paclitaxel 60mg/m2 IV weekly; Oxaliplatin 50mg/m2 IV weekly; Leucovorin 20 mg/m2 IV weekly, minimum of 40 mg; 5FU 425mg/m2 IV weekly; Weekly for 12 weeks; Calcium and magnesium 1gram each IV prior to and after Oxaliplatin therapy; Glutathione 1500mg/m2 prior to Oxaliplatin DURATION OF STUDY PERIOD: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay greater than 3 weeks, 12 weeks initially, can than continue at discretion of investigator. EXPECTED NUMBER OF PATIENTS: A total of 80 patients (40 second line of treatment and 40 third line or greater of treatment) will be enrolled for this study beginning in May 2006. QUALITY OF LIFE: Quality of life will be assessed at baseline, each month of treatment and at the end of study therapy.

Adenocarincoma of Pancreas
Stage III Pancreatic Cancer
Stage IVA Pancreatic Cancer
Stage IVB Pancreatic Cancer

DRUG: paclitaxel
DRUG: oxaliplatin
DRUG: leucovorin
DRUG: 5-fluorouracil
DRUG: glutathione
DRUG: calcium and magnesium
PROCEDURE: Chemotherapy
PROCEDURE: Chemoprotection
PROCEDURE: Complementary and alternative therapy

CTCA06-02

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 2006-05-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2007-05-07
First Submitted that Met QC Criteria 2006-05-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2007-05-08
First Posted (ESTIMATED) 2006-05-09	Results First Posted N/A	Last Verified 2007-05

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
Clinical response rate (PS improvement by ECOG score, analgesic dose reduction)
Response Rate Recist (Uni-Dimensional) Criteria
Progression free survival
Median survival
Overall survival
Quality of life

Secondary Outcome Measures	Measure Description	Time Frame
Tolerance and Safety NCI-CTC version 2

Contacts and Locations

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

Study Contact

Name: Ben Chue, MD

Phone Number: 206-292-2277

Email:

Study Contact Backup

Name: Nick Chen, MD

Phone Number: 206-292-2277

Email: nickc@seattlecancerwellness.com

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:

Both

For advanced disease allowed as above;
Oxaliplatin or 5-FU will be allowed but a subset analysis will be done for this group of patients;
Tarceva and/or Erbitux allowed, but subset analysis will be done.

No known allergy to one of the study drugs

No CNS metastases
No peripheral neuropathy > grade 2
ECOG Performance Status <=2
Age ≤ 65
No other serious concomitant illness
Fully recovered from any prior therapy

≤ 65

ANC >1500
Platelets >75,000
Creatinine <=2.0

For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception

Performance state >=3
Uncontrolled serious concomitant disease
Radiotherapy within the 6 weeks before Cycle 1' Day 1
Surgery within the 2 weeks before Cycle 1' Day 1

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Ben Chue, MD, Seattle Cancer Treatment and Wellness Center

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

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Clinical Trial Record