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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Cancer Treatment and Wellness Center
• Treatments: Albumin-Bound Paclitaxel; Calcium; Fluorouracil; Leucovorin; Oxaliplatin; Paclitaxel

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