Copyright
©The Author(s) 2015.
World J Gastroenterol. Apr 28, 2015; 21(16): 4788-4801
Published online Apr 28, 2015. doi: 10.3748/wjg.v21.i16.4788
Published online Apr 28, 2015. doi: 10.3748/wjg.v21.i16.4788
Table 1 Selected adjuvant or “strategy” (neoadjuvant vs adjuvant) clinical trials employing contemporary treatment regimens for resectable pancreatic adenocarcinoma
| Study ID1 | Design | Phase | Estimated accrual | Status |
| NCT00882310 | Adjuvant Gem, Taxotere, and Xeloda | II | 32 | Active, not recruiting |
| NCT00960284 | Post-operative Gemcitabine vs PEFG Followed by Chemoradiation | II/III | 102 | Completed |
| NCT01150630 | Adjuvant Gem vs Adjuvant PEXG vs Neoadjuvant/Adjuvant PEXG | II/III | 370 | Recruiting |
| NCT01526135 | Adjuvant Gem vs modified FOLFIRINOX2 | III | 490 | Recruiting |
| NCT01660711 | Neoadjuvant/Adjuvant modified FOLFIRINOX3 | II | 21 | Recruiting |
| NCT01845805 | Adjuvant nab-Paclitaxel/Gem/Azacitidine | II | 80 | Recruiting |
| NCT01964430 | Adjuvant Gem vs nab-Paclitaxel/Gem (APACT) | III | 800 | Recruiting |
| NCT02023021 | Adjuvant nab-Paclitaxel/Gem | II | 80 | Recruiting |
| NCT02047474 | Neoadjuvant/Adjuvant modified FOLFIRINOX4 | II | 46 | Recruiting |
| NCT02047513 | Adjuvant only vs Neoadjuvant/Adjuvant nab-Paclitaxel/Gem (NEONAX) | RII5 | 166 | Not yet recruiting |
| NCT02172976 | Adjuvant Gemcitabine vs Neoadjuvant/Adjuvant FOLFIRINOX | II/III | 126 | Not yet recruiting |
Table 2 Selected ongoing studies of contemporary “nanoparticle albumin-paclitaxel-based” systemic therapy in borderline resectable, locally advanced and metastatic pancreatic cancer
| Title (Study ID1) | Phase | Stage | Status |
| Randomized Phase II Trial of Pre-Operative Gemcitabine and nab-Paclitaxel With or With Out Hydroxychloroquine (NCT01978184) | Phase 2 | Potentially resectable | Recruiting |
| Phase 1/2 Safety and Feasibility of Gemcitabine and nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma (NCT01431794) | Phase 1Phase 2 | Resectable | Recruiting |
| A Pilot Phase II Multi Center Study of Gemcitabine and nab-Paclitaxel (Abraxane) as Preoperative Therapy for Potentially Operable Pancreatic Cancer (NCT01298011) | Phase 2 | Resectable | Active, not recruiting |
| Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer (NCT02243007) | Phase 2 | Resectable | Not yet 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 |
| Nab-Paclitaxel Plus Gemcitabine With Concurrent MR-Guided IMRT in Patients With Locally Advanced and Borderline Resectable Pancreatic Cancer (NCT02283372) | Phase 1 | BR or LA | Not yet recruiting |
| A Phase I Dual Dose Escalation Study of Radiation and nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer (NCT02207465) | Phase 1 | BR or LA unresectable | Recruiting |
| A Phase 2 Trial of Gemcitabine Plus nab-Paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer (NCT02210559) | Phase 2 | LA, unresectable | Recruiting |
| A Phase I Study of Chemoradiotherapy Using Gemcitabine Plus nab-Paclitaxel for Unresectable Locally Advanced Pancreatic Adenocarcinoma (NCT02272738) | Phase 1 | LA, unresectable | Recruiting |
| A Phase 1, Multicenter, Open-label, Dose-escalation Study to Investigate the Safety and Pharmacokinetics of Nab® - Paclitaxel (ABI-007) Plus Gemcitabine in Subjects With Advanced Pancreatic Cancer Who Have Cholestatic Hyperbilirubenemia Secondary to Bile Duct Obstruction (NCT02267707) | Phase 1 | LA unresectable or metastatic | Not yet recruiting |
| Evaluation of Tumoral Perfusion Modification by Dynamic Imaging After Chemotherapy Combining Gemcitabine and nab-Paclitaxel (Abraxane) in Patients With Potentially Operable, Locally Advanced or Metastatic Pancreatic Adenocarcinoma (NCT01715142) | Phase 0 | Stage I-II-III-IV | Not yet recruiting |
| A Phase II Randomized Trial Comparing a Combination of Abraxane and Gemcitabine Versus Gemcitabine Alone as First Line Treatment in Locally Advanced Unresectable Pancreatic Cancer. GAP (Gemcitabine Abraxane Pancreas) Trial (NCT02043730) | Phase 2 | Stage III | Active, not recruiting |
| A Multicenter Phase I/II Randomized Phase II Study of Gemcitabine and nab-Paclitaxel With or Without NPC-1C in Patients With Metastatic or Locally Advanced Pancreatic Cancer (NCT01834235) | Phase 1Phase 2 | Stage III-IV | Recruiting |
| A Phase IB Study of Erlotinib in Combination With Gemcitabine and nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer (NCT01010945) | Phase 1 | Stage III-IV | Completed |
| A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX7486 as a Single Agent and in Combination With Gemcitabine and nab-Paclitaxel in Patients With Advanced Solid Tumors (NCT01804530) | Phase 1 | Stage III-IV | Recruiting |
| An Open-Label, Phase I Dose Escalation Trial of TH-302 in Combination With Gemcitabine and Nab-Paclitaxel in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma (NCT02047500) | Phase 1 | Stage III-IV | Recruiting |
| Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus nab-Paclitaxel in the Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer (NCT01851174) | Phase 2 | Stage III-IV | Recruiting |
| Phase 1B Trial of ADI-PEG 20 Plus nab-Paclitaxel and Gemcitabine in Subjects With Advanced Pancreatic Cancer (NCT02101580) | Phase 1 | Stage III-IV | Not yet recruiting |
| Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy (NCT00691054) | Phase 2 | Stage III-IV | Completed |
| A Phase I/II/Pharmacodynamic Study of Hydroxychloroquine in Combination With Gemcitabine/Abraxane to Inhibit Autophagy in Pancreatic Cancer (NCT01506973) | Phase 1Phase 2 | Stage III-IV | Recruiting |
| BYL719 in Combination With Gemcitabine and (Nab)-Paclitaxel in Locally Advanced and Metastatic Pancreatic Cancer (NCT02155088) | Phase 1 | Stage III-IV | Recruiting |
| A Phase I and Randomized, Double-Blinded Phase II Study of nab-paclitaxel/Gemcitabine Plus AZD1775 or Placebo in Treatment-Naïve Metastatic Adenocarcinoma of the Pancreas (NCT02194829) | Phase 1Phase 2 | Stage III-IV | Suspended |
| A Phase Ib Study of Dovitinib in Combination With Gemcitabine and nab-Paclitaxel in Patients With Advanced Solid Tumors and Pancreatic Cancer (NCT02048943) | Phase 1 | Stage III-IV-recurrent | Not yet 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 |
| A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer (NCT02005315) | Phase 1 | Stage IV | Recruiting |
| A Phase 1b Dose Escalation Study of OMP-54F28 in Combination With nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer (NCT02050178) | Phase 1 | Stage IV | Recruiting |
| A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Combined With nab-Paclitaxel Plus Gemcitabine Compared With nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer (NCT01839487) | Phase 2 | Stage IV | Recruiting |
| A Phase I/II Study of Indoximod in Combination With Gemcitabine and nab-Paclitaxel in Patients With Metastatic Adenocarcinoma of the Pancreas (NCT02077881) | Phase 1Phase 2 | Stage IV | Not yet recruiting |
| A Phase 1b/2 Study of OMP-59R5 in Combination With nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer (NCT01647828) | Phase 1Phase 2 | Stage IV | Recruiting |
| Phase I Trial of the Proapoptotic Agonist, LCL161, and Gemcitabine Plus nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer (NCT01934634) | Phase 1 | Stage IV | Recruiting |
| A Phase I Study of nab-paclitaxel (Abraxane), Gemcitabine, and Capecitabine (Xeloda) (AGX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma (NCT01161186) | Phase 1 | Stage IV | Completed |
| A Phase 1b/2 Pilot Trial of nab-Paclitaxel Plus Cisplatin Plus Gemcitabine (Nabplagem) in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA) (NCT01893801) | Phase 1Phase 2 | Stage IV | Recruiting |
| A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination With nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer (NCT01621243) | Phase 1Phase 2 | Stage IV | Recruiting |
| A Phase 2, Randomized, Double-blind Study of Gemcitabine And nab-Paclitaxel Combined With Momelotinib in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma Preceded by a Dose-finding, Lead-in Phase (NCT02101021) | Phase 2 | Stage IV | Not yet recruiting |
| Phase 1/2 Study Of PF-03084014 In Combination With Gemcitabine And nab-Paclitaxel In Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (NCT02109445) | Phase 1Phase 2 | Stage IV | Not yet 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 |
| A Randomized, Double-Blinded, Placebo-Controlled Phase II Trial Of Gemcitabine Plus nab-Paclitaxel Combined With OGX-427 Or Placebo In Patients With Metastatic Pancreatic Cancer (The Rainier Trial) (NCT01844817) | Phase 2 | Stage IV | Recruiting |
| A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer (NCT02242409) | Phase 2 | Stage IV | Recruiting |
| Enzalutamide in Combination With Gemcitabine and nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer (NCT02138383) | Phase 1 | Stage IV | Recruiting |
| A Phase Ib/II Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330, Gemcitabine and nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer (NCT02178436) | Phase 1Phase 2 | Stage IV | Not yet recruiting |
| Phase II Trial of nab-Paclitaxel Plus S-1 in First-line Treatment of Patients With Advanced Pancreatic Cancer (NCT02124317) | Phase 2 | Stage IV | Recruiting |
| Biological Effect of nab-Paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer (NCT02174887) | Phase 1 | Stage IV | Not yet recruiting |
| A 3-Arm Phase 2 Double-Blind Randomized Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma (NCT02289898) | Phase 2 | Stage IV | Not yet recruiting |
| A Phase Ib Clinical Study of BBI608 in Combination With Gemcitabine and nab-Paclitaxel in Adult Patients With Metastatic Pancreatic Adenocarcinoma (NCT02231723) | Phase 1 | Stage IV | Recruiting |
| Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer (NCT02135822) | Phase 2 | Advanced | Recruiting |
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 |
- Citation: Vaccaro V, Sperduti I, Vari S, Bria E, Melisi D, Garufi C, Nuzzo C, Scarpa A, Tortora G, Cognetti F, Reni M, Milella M. Metastatic pancreatic cancer: Is there a light at the end of the tunnel? World J Gastroenterol 2015; 21(16): 4788-4801
- URL: https://www.wjgnet.com/1007-9327/full/v21/i16/4788.htm
- DOI: https://dx.doi.org/10.3748/wjg.v21.i16.4788