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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00323583
Recruitment Status : Unknown
Verified May 2007 by Seattle Cancer Treatment and Wellness Center.
Recruitment status was:  Recruiting
First Posted : May 9, 2006
Last Update Posted : May 8, 2007
Information provided by:
Seattle Cancer Treatment and Wellness Center

Brief Summary:

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 or disease Intervention/treatment 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 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory Advanced Pancreatic Cancer
Study Start Date : May 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Clinical response rate (PS improvement by ECOG score, analgesic dose reduction)
  2. Response Rate Recist (Uni-Dimensional) Criteria
  3. Progression free survival
  4. Median survival
  5. Overall survival
  6. Quality of life

Secondary Outcome Measures :
  1. Tolerance and Safety NCI-CTC version 2

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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.


  • 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

Lower Age Limit:

  • >18

Upper Age Limit:

  • ≤ 65


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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00323583

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Contact: Ben Chue, MD 206-292-2277
Contact: Nick Chen, MD 206-292-2277

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United States, Washington
Seattle Cancer Treatment and Wellness Center Recruiting
Seattle, Washington, United States, 98112
Contact: Nick Chen, MD    206-292-2277   
Contact: Jerry Kaufman    206-292-2277   
Sponsors and Collaborators
Seattle Cancer Treatment and Wellness Center
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Principal Investigator: Ben Chue, MD Seattle Cancer Treatment and Wellness Center
Additional Information:
Layout table for additonal information Identifier: NCT00323583    
Other Study ID Numbers: CTCA06-02
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: May 8, 2007
Last Verified: May 2007
Keywords provided by Seattle Cancer Treatment and Wellness Center:
Pancreatic Cancer
Cancer Alternative Therapies
Living with Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Protective Agents
Vitamin B Complex