Metastatic Pancreatic Cancer Clinical Trial
Official title:
Efficacy and Safety of Modified Nab-Paclitaxel Plus Gemcitabine Chemotherapy for Metastatic Pancreatic Cancer: A Single-arm Phase II Clinical Trial
Recently, a retrospective study reported the efficacy and safety of modified gemcitabine plus
nab-paclitaxel (GnP), which were administered biweekly (on days 1 and 15). With 79 patients
of metastatic pancreatic cancer, this study reported similar efficacy and improved toxicity
profile compared with standard dose GnP (OS 10 months, PFS 5.4 months, Grade ≥3 Neutropenia
19%, Grade ≥3 sensory neuropathy 1.6%). Also, several studies reported that dose reduction of
nab-paclitaxel in breast or pancreatic cancer treatment was not related of decreased
survival, or related with prolonged survival and increased treatment exposure. However, this
finding need to be evaluated in prospective clinical trial.
This phase II trial will evaluate the efficacy and safety of modified GnP, which omit the day
8 administration of nab-paclitaxel, in metastatic pancreatic cancer.
Gemcitabine-based combination therapy have been used to prolong survival for patient with
pancreatic cancer. In early 2010s, gemcitabine plus nab-paclitaxel (GnP) combination regimen
have been introduced based on the results of randomized phase III clinical trial that showed
survival benefit than gemcitabine monotherapy. Nab-paclitaxel is a nanoparticle albumin-bound
paclitaxel that showed anti-tumor activity as well as synergistic effect in combination with
gemcitabine.
In the Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT), the maximal tolerated
nab-paclitaxel dose (125 mg/m2) was administrated with 1000 mg/m2 of gemcitabine, on days 1,
8 and 15 for 4 weeks cycle. This combination therapy showed favorable treatment response, but
notable severe adverse events were also reported. Grade 3 or higher neuropathy and
neutropenia occurred in 17% and 38% of patients, respectively. Also, dose reduction was
required in approximately half of the patients.
Recently, a retrospective study reported the efficacy and safety of modified GnP, which were
administered biweekly (on days 1 and 15). With 79 patients of metastatic pancreatic cancer,
this study reported similar efficacy and improved toxicity profile compared with standard
dose GnP (OS 10 months, PFS 5.4 months, Grade ≥3 Neutropenia 19%, Grade ≥3 sensory neuropathy
1.6%). Also, several studies reported that dose reduction of nab-paclitaxel in breast or
pancreatic cancer treatment was not related of decreased survival, or related with prolonged
survival and increased treatment exposure. However, this finding need to be evaluated in
prospective clinical trial.
This phase II trial will evaluate the efficacy and safety of modified GnP, which omit the day
8 administration of nab-paclitaxel, in metastatic pancreatic cancer.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04753879 -
Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.
|
Phase 2 | |
| Completed |
NCT01417000 -
Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02975141 -
Afatinib and Gemcitabine/Nab-paclitaxel in Metastatic Pancreatic Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT00761345 -
Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer
|
Phase 1 | |
| Completed |
NCT00919282 -
Gemcitabine (GFF) in Patients With Pancreatic Cancer
|
Phase 2 | |
| Completed |
NCT01088815 -
Hedgehog Inhibitors for Metastatic Adenocarcinoma of the Pancreas
|
Phase 2 | |
| Completed |
NCT04133155 -
Retrospective Analysis of 2nd-line Nab-Paclitaxel + Gemcitabine After 1st-line FOLFIRINOX in Pancreatic Cancer
|
||
| Withdrawn |
NCT05251038 -
Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04612530 -
PANFIRE-3 Trial: Assessing Safety and Efficacy of Irreversible Electroporation (IRE) + Nivolumab + CpG for Metastatic Pancreatic Cancer
|
Phase 1 | |
| Completed |
NCT03602885 -
EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options
|
N/A | |
| Recruiting |
NCT05442749 -
Niraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer
|
Phase 2 | |
| Recruiting |
NCT04222413 -
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT03721744 -
A Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer
|
Phase 2/Phase 3 | |
| Completed |
NCT03261947 -
A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors
|
Phase 2 | |
| Withdrawn |
NCT06017323 -
Proglumide With Gemcitabine and Nab-Paclitaxel in PatientsWith Metastatic Pancreatic Ductal Adenocarcinoma
|
Phase 1 | |
| Terminated |
NCT01946646 -
Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer
|
Phase 1 | |
| Completed |
NCT01523457 -
Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT00986661 -
A Study to Assess PV-10 Chemoablation of Cancer of the Liver
|
Phase 1 | |
| Terminated |
NCT00726037 -
A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer
|
Phase 2 | |
| Completed |
NCT00744640 -
Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma
|
Phase 1/Phase 2 |