ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer

This study is currently recruiting participants.
Verified by Seattle Cancer Treatment and Wellness Center, May 2007

Sponsored by: Seattle Cancer Treatment and Wellness Center
Information provided by: Seattle Cancer Treatment and Wellness Center
ClinicalTrials.gov Identifier: NCT00323583
  Purpose

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.


Condition Intervention Phase
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
Phase II

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

ChemIDplus related topics:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Gemcitabine hydrochloride    Gemcitabine    Paclitaxel    Magnesium    Fluorouracil    Oxaliplatin    Calcium gluconate    Glutathione   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory Advanced Pancreatic Cancer

Further study details as provided by Seattle Cancer Treatment and Wellness Center:

Primary Outcome Measures:
  • 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:
  • Tolerance and Safety NCI-CTC version 2

Estimated Enrollment:   80
Study Start Date:   May 2006

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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323583

Contacts
Contact: Ben Chue, MD     206-292-2277    
Contact: Nick Chen, MD     206-292-2277     nickc@seattlecancerwellness.com    

Locations
United States, Washington
Seattle Cancer Treatment and Wellness Center     Recruiting
      Seattle, Washington, United States, 98112
      Contact: Nick Chen, MD     206-292-2277     nickc@seattlecancerwellness.com    
      Contact: Jerry Kaufman     206-292-2277     jerryk@seattelcancerwellness.com    

Sponsors and Collaborators
Seattle Cancer Treatment and Wellness Center

Investigators
Principal Investigator:     Ben Chue, MD     Seattle Cancer Treatment and Wellness Center    
  More Information

Seattle Cancer Treatment and Wellness Center  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CTCA06-02
First Received:   May 5, 2006
Last Updated:   May 7, 2007
ClinicalTrials.gov Identifier:   NCT00323583
Health Authority:   United States: Institutional Review Board

Keywords provided by Seattle Cancer Treatment and Wellness Center:
Cancer  
Pancreatic Cancer  
Cancer Alternative Therapies  
Living with Cancer  

Study placed in the following topic categories:
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Leucovorin
Oxaliplatin
Digestive System Diseases
Paclitaxel
Fluorouracil
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Tubulin Modulators
Micronutrients
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on August 20, 2008




Links to all studies - primarily for crawlers