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

May 7, 2007 updated by: Seattle Cancer Treatment and Wellness Center

Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 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

Study Contact Backup

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS

Patients with pathologically-proven pancreatic adenocarcinoma, who

  1. are not candidate for surgery
  2. are not candidate for radiation therapy and
  3. have failed gemcitabine-based chemotherapy regimen

Gender Eligible for Study:

  • Both

Prior Therapy:

  • 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.

Allergies:

  • No known allergy to one of the study drugs

PATIENT CHARACTERISTICS:

  • 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

Lower Age Limit:

  • >18

Upper Age Limit:

  • ≤ 65

Laboratory:

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

Other:

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

Exclusion Criteria:

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Tolerance and Safety NCI-CTC version 2

Collaborators and Investigators

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

Sponsor

Seattle Cancer Treatment and Wellness Center

Investigators

  • Principal Investigator: Ben Chue, MD, Seattle Cancer Treatment and Wellness Center

Publications and helpful links

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

Helpful Links

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 Major Dates

Study Start

May 1, 2006

Study Registration Dates

First Submitted

May 5, 2006

First Submitted That Met QC Criteria

May 5, 2006

First Posted (ESTIMATE)

May 9, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2007

Last Update Submitted That Met QC Criteria

May 7, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTCA06-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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