Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | May 2006 |
| Contact: | Ben Chue, MD |
| Phone: | 206-292-2277 |
Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory Advanced Pancreatic Cancer
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.
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.
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.
- 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.
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
We found this trial at
1
site
Click here to add this to my saved trials
