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

Phase 2

• Conditions: Stage III Pancreatic Cancer; Adenocarincoma of Pancreas; Stage IVB Pancreatic Cancer; Stage IVA Pancreatic Cancer

• Registration Number: NCT00323583
• Lead Sponsor: Seattle Cancer Treatment and Wellness Center

Brief Summary

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.

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-05
• Study First Submitted QC: 2006-05-05
• Study First Posted: 2006-05-09
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-07
• Last Update Posted: 2007-05-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression free survival
Median survival
Clinical response rate (PS improvement by ECOG score, analgesic dose reduction)
Response Rate Recist (Uni-Dimensional) Criteria
Overall survival
Quality of life

Secondary Outcome Measures

Name	Time	Method
Tolerance and Safety NCI-CTC version 2

Trial Locations

Locations (1)

Seattle Cancer Treatment and Wellness Center; 🇺🇸 Seattle, Washington, United States