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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Adenocarincoma of Pancreas, Stage III Pancreatic Cancer, Stage IVA Pancreatic Cancer, Stage IVB Pancreatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response rate (PS improvement by ECOG score, analgesic dose reduction)

Principal Investigator

Ben Chue, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seattle Cancer Treatment and Wellness Center

Authority:

United States: Institutional Review Board

Study ID:

CTCA06-02

NCT ID:

NCT00323583

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Adenocarincoma of Pancreas
  • Stage III Pancreatic Cancer
  • Stage IVA Pancreatic Cancer
  • Stage IVB Pancreatic Cancer
  • Cancer
  • Pancreatic Cancer
  • Cancer Alternative Therapies
  • Living with Cancer
  • Pancreatic Neoplasms

Name

Location

Seattle Cancer Treatment and Wellness Center Seattle, Washington  98112