Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarincoma of Pancreas | — | UNRESOLVED | — |
| Stage III Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVA Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVB Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| calcium and magnesium | Drug | — | UNRESOLVED |
| Chemoprotection | Procedure | — | UNRESOLVED |
| Chemotherapy | Procedure | — | UNRESOLVED |
| Complementary and alternative therapy | Procedure | — | UNRESOLVED |
| glutathione | Drug | — | UNRESOLVED |
| leucovorin | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| paclitaxel | Drug |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Clinical response rate (PS improvement by ECOG score, analgesic dose reduction)
- measure
- Response Rate Recist (Uni-Dimensional) Criteria
- measure
- Progression free survival
- measure
- Median survival
- measure
- Overall survival
- measure
- Quality of life
Secondary outcomes (1)
- measure
- Tolerance and Safety NCI-CTC version 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available