Trial | NCT00323583  Report issue

Title

Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer
Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory Advanced Pancreatic Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
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.
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.
Study Started
May 31
2006
Last Update
May 08
2007
Estimate

Drug paclitaxel

Drug oxaliplatin

Drug leucovorin

Drug 5-fluorouracil

Drug glutathione

Drug calcium and magnesium

Procedure Chemotherapy

Procedure Chemoprotection

Procedure Complementary and alternative therapy

Criteria 

DISEASE CHARACTERISTICS

Patients with pathologically-proven pancreatic adenocarcinoma, who

are not candidate for surgery
are not candidate for radiation therapy and
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
No Results Posted