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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Seattle Cancer Treatment and Wellness Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seattle Cancer Treatment and Wellness Center
ClinicalTrials.gov Identifier:
NCT00323583
First received: May 5, 2006
Last updated: May 7, 2007
Last verified: May 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory Advanced Pancreatic Cancer

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00323583     History of Changes
Other Study ID Numbers: CTCA06-02
Study First Received: May 5, 2006
Last Updated: May 7, 2007
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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Oxaliplatin
Paclitaxel
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators

ClinicalTrials.gov processed this record on August 01, 2014