Table 3.
Selected ongoing studies of ”folfirinox-based”and other contemporary regimens in borderline resectable, locally advanced and metastatic pancreatic cancer
| Title (Study ID1) | Phase | Stage | Status |
| A Phase II Study of Neoadjuvant FOLFIRINOX in Patients With Resectable Pancreatic Ductal Adenocarcinoma With Tissue Collection (NCT02178709) | Phase 2 | Resectable | Recruiting |
| Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/nab-Paclitaxel in Patients With Resectable Pancreatic Cancer (NCT02243007) | Phase 2 | Resectable | Not yet recruiting |
| Neoadjuvant CAPOXIRI Chemotherapy in the Treatment of Resectable, Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma Protocol (NCT01760252) | Phase 2 | Resectable, BR and LA | Recruiting |
| GTX-RT in Borderline Resectable Pancreatic Cancer (NCT01754623) | Phase 2 | BR | Active, not recruiting |
| Neoadjuvant FOLFIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study (NCT02148549) | Phase 1 | BR | Recruiting |
| Phase II Neoadjuvant Chemotheraphy (Gemcitabine and nab-Paclitaxel vs mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer (NCT02241551) | Phase 2 | BR | Not yet recruiting |
| Phase IB Study of FOLFIRINOX Plus PF-04136309 in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma (NCT01413022) | Phase 1 | BR or LA | Recruiting |
| Phase II Single Arm Clinical Trial of FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer (NCT01688336) | Phase 2 | BR or LA unresectable | Recruiting |
| Prospective Randomized Multicenter Phase II Trial to Investigate Intensified Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer (NEOLAP) (NCT02125136) | Phase 2 | LA | Not yet recruiting |
| The Effect of FOLFIRINOX and Stereotactic Body Radiation Therapy for Locally Advanced, Non-Resectable Pancreatic Cancer (BCC-RAD-13) (NCT02128100) | Phase 2 | LA, unresectable | Not yet recruiting |
| A Phase II, Randomized, Open Label Study of Single Dose siG12D LODER in Combination With Chemotherapy in Patients With Unresectable Locally Advanced Pancreatic Cancer (NCT01676259) | Phase 2 | LA, unresectable | Not yet recruiting |
| A Prospective Evaluation of Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancreas Cancer (Baylor University Medical Center and Texas Oncology Experience) (NCT01771146) | Not provided | Localized, Non-metastatic | Recruiting |
| Phase 1b Clinical Trial of LDE225 in Combination With Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX) in Previously Untreated Locally Advanced or Metastatic Pancreatic Adenocarcinoma, With an Expansion Cohort at the Recommended Phase 2 Dose (NCT01485744) | Phase 1 | LA unresectable or metastatic | Recruiting |
| A Phase I Study of FOLFIRINOX Plus IPI-926 for Advanced Pancreatic Adenocarcinoma (NCT01383538) | Phase 1 | Not provided | Active, not recruiting |
| Phase II Study: Neoadjuvant Gemcitabine, Docetaxel and Capecitabine Followed by Neoadjuvant Radiation Therapy With Gemcitabine and Capecitabine in the Treatment of Stage II and III Pancreatic Adenocarcinoma (NCT01065870) | Phase 2Phase 3 | Stage II-III | Recruiting |
| A Phase I-II Study of PAXG in Stage III-IV Pancreatic Adenocarcinoma (NCT01730222) | Phase 1-2 | Stage III-IV | Recruiting |
| Phase II Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer (NCT01523457) | Phase 2 | Stage III-IV | Recruiting |
| Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer (NCT02227940) | Phase 1 | Stage III-IV, recurrent | Not yet recruiting |
| Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab in Combination With Allogeneic GM-CSF Transfected Pancreatic Tumor Vaccine (GVAX) in the Treatment of Metastatic Pancreatic Cancer (NCT01896869) | Phase 2 | Stage IV | Recruiting |
| A Phase II Study of Induction Consolidation and Maintenance Approach for Patients With Advanced Pancreatic Cancer (NCT01488552) | Phase 1-2 | Stage IV | Recruiting |
| A Phase I Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer and Good Performance Status (NCT01835041) | Phase 1 | Stage IV | Recruiting |
| Phase IB/Randomized Phase II Study of Folfirinox Plus AMG-479 (Ganitumab) or Placebo in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma (NCT01473303) | Phase 1Phase 2 | Stage IV | Withdrawn |
| Phase II Trial to Investigate the Efficacy and Safety of mFOLFIRINOX in Patients With Metastatic Pancreatic Cancer in China (NCT02028806) | Phase 2 | Stage IV | Recruiting |
| S1313, A Phase IB/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) Versus Modified FOLFIRINOX Alone in Patients With Good Performance Status Metastatic Pancreatic Adenocarcinoma (NCT01959139) | Phase 1Phase 2 | Stage IV | Recruiting |
| Phase I-II Trial of Gemcitabine Plus nab-Paclitaxel (GemBrax) Followed by Folfirinox as First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (NCT01964287) | Phase 1Phase 2 | Stage IV | Recruiting |
| Phase II Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer (NCT01523457) | Phase 2 | Stage IV | Recruiting |
| Phase I/II Study to Evaluate nab-Paclitaxel in Substitution of CPT11 or Oxaliplatin in FOLFIRINOX Schedule as First Line Treatment in Metastatic Pancreatic Cancer (NCT02109341) | Phase 1Phase 2 | Stage IV | Recruiting |
| Phase II Study for Inoperable Non-Metastatic Pancreatic Cancer (Stage IVA) With Neoadjuvant Gemzar, Taxotere and Xeloda (GTX), and Radiation With Gemzar (NCT00869258) | Phase 2 | Stage IV | Active, not recruiting |
| Phase II Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin in Subjects With Metastatic Pancreatic Cancer (NCT01459614) | Phase 2 | Stage IV | Active, not recruiting |
| Phase-2 Study Evaluating Overall Response Rate (Efficacy) and Autonomy Daily Living Preservation (Tolerance) of "FOLFIRINOX " Pharmacogenetic Dose Adjusted, in Elderly Patients (70 yr or Older) With a Metastatic Pancreatic Adenocarcinoma (NCT02143219) | Phase 2 | Stage IV | Not yet recruiting |
1
ClinicalTrials.gov Identifier. BR: Borderline resectable; LA: Locally advanced; nab-Paclitaxel: Nanoparticle albumin-bound paclitaxel.