Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory Advanced Pancreatic Cancer
18 Years
65 Years
Both
Adenocarincoma of Pancreas, Stage III Pancreatic Cancer, Stage IVA Pancreatic Cancer, Stage IVB Pancreatic Cancer
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 |
