scholarly journals A Phase 1b clinical trial of LDE225 (Sonidegib) in combination with fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFIRINOX) in previously untreated locally advanced or metastatic pancreatic adenocarcinoma

2021 ◽  
Vol 0 ◽  
pp. 0-0
Author(s):  
Jeffrey W. Clark ◽  
Nora Horick ◽  
Jill N. Allen ◽  
Lawrence S. Blaszkowsky ◽  
Janet E. Murphy ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pancreatic Adenocarcinoma ◽  
Locally Advanced ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Phase 1B

Modified FOLFIRINOX as a second-line treatment in pancreatic adenocarcinoma patients with poor performance status.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15796-e15796
Author(s):  
Adarsh Das ◽  
Andrew Peter Dean ◽  
Domenic Higgs
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Performance Status ◽  
Locally Advanced ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Line Treatment ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Metastatic Pancreatic Adenocarcinoma

e15796 Background: FOLFIRINOX is well known to be a highly effective treatment in pancreatic cancer for young patients with good performance status. As the original ACCORD study was carried out with patient’s performance status 0 or 1, many oncologists feel uncertain administering modified dose FOLFIRINOX (m-FOLFIRINOX) as a second-line therapy. We have previously reported our experience in 35 patients (aged 27 – 85) where we concluded that m-FOLFIRINOX can be administered safely with appropriate dose reductions. More recently, the systematic review and meta-analysis by Tong et al. concluded that m-FOLFIRINOX is a good choice of therapy even for those with poor performance status. This retrospective analysis assessed the efficacy of m-FOLFIRINOX in second-line treatment of pancreatic adenocarcinoma. Methods: Using an electronic database, patients with either locally advanced or metastatic pancreatic adenocarcinoma were identified who had received first-line gemcitabine plus nab-paclitaxel, followed by second-line m-FOLFIRINOX between January 2013 and July 2018. All patients had an ECOG performance status of 2 or less. Overall survival (OS) was estimated by the Kaplan-Meier method. Results: Fifty-two patients were identified, with 65% of the patients having metastatic pancreatic disease. Median age of patients was 75 (range, 27 – 86). Dose intensity of m-FOLFIRINOX was 65% for oxaliplatin, 68% for irinotecan, 18% for bolus 5-fluorouracil (5-FU) and 68% for infusional 5-FU. From diagnosis, the median OS of all patients was 45.0 months (95% CI, 25.0 – 63.0). The median OS of the locally advanced and metastatic pancreatic adenocarcinoma was 63.0 months (95% CI, 45.0 – 70.0) and 22.5 months (95% CI, 18.0, 38.0), respectively. Conclusions: Our study demonstrates the safety and efficacy of m-FOLFIRINOX as a second-line therapy after gemcitabine plus nab-paclitaxel failure. These findings correlate with the findings of Tong et al.’s findings of the benefits of m-FOLFIRINOX for advanced pancreatic cancer in patients with poor performance status.

A randomized, phase II clinical trial of preoperative stereotactic body radiation therapy versus conventionally fractionated chemoradiation for resectable, borderline-resectable, or locally advanced type a pancreatic adenocarcinoma.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS4167-TPS4167
Author(s):  
William Adrian Hall ◽  
Susan Tsai ◽  
Anjishnu Banerjee ◽  
Ben George ◽  
Paul S. Ritch ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiation Therapy ◽  
Neoadjuvant Chemotherapy ◽  
Pancreatic Adenocarcinoma ◽  
Phase Ii ◽  
Stereotactic Body Radiation Therapy ◽  
Locally Advanced ◽  
Phase Ii Clinical Trial ◽  
Borderline Resectable ◽  
Conventionally Fractionated

TPS4167 Background: There is growing consensus for the use of neoadjuvant therapy in patients with potentially operable pancreatic adenocarcinoma (PC). However, there is not consensus on the type and duration of chemotherapy or radiation therapy (RT) dose. Stereotactic body radiation therapy (SBRT) has gained popularity despite the absence of prospective data for its use in the preoperative setting. Furthermore, SBRT preoperatively has not been standardized. At present, there exists no randomized data comparing preoperative SBRT with conventionally fractionated concurrent chemo-RT. We designed this trial to examine differences between pre-op RT dose and fractionation schedules. Methods: This study is a prospective, randomized, two-arm, phase II clinical trial. Eligible patients must have cytologically confirmed PC and be deemed suitable for surgical resection with resectable, borderline resectable, or locally advanced type A disease, based on cross-sectional imaging. Before randomization patients are stratified by clinical node positivity, neoadjuvant chemotherapy, and stage of disease. Patients are then randomized to either 50.4 Gy over 28 fractions with concurrent weekly Gemcitabine vs SBRT to a total dose of 25-35 Gy over 5 fractions. The primary endpoint of the study is pathologic node positivity. We hypothesize that patients treated with neoadjuvant chemotherapy followed by conventionally fractionated chemo-RT will have a lower rate of pathologic node positivity as compared to those patients treated with neoadjuvant chemotherapy followed by SBRT. Secondary endpoints include patient reported quality of life, local recurrence, primary tumor pathologic response, margin status, surgical complications, MR based treatment response, and overall survival. We anticipate a node positivity rate of 37% when using preoperative chemotherapy followed by SBRT. We hypothesize that treatment with chemotherapy followed by conventionally fractionated chemo-RT will reduce the rate of node positivity to 17%. Using a one-sided Type I error rate of 0.1, approximately 88 total patients (44 per arm) provide an 80% power to detect the hypothesized difference in pathologic node positivity between the two arms. To address patient dropout, an additional 14 patients (about 15%) will be enrolled for a total target accrual of 102 patients. The trial opened in November 2018 and 8 of the planned 102 patients have been enrolled. Clinical trial information: NCT03704662.

A Phase II Trial of Perifosine in Locally Advanced, Unresectable, or Metastatic Pancreatic Adenocarcinoma

2007 ◽  
Vol 30 (1) ◽  
pp. 26-31 ◽  
Author(s):  
Robert de W. Marsh ◽  
C M. Rocha Lima ◽  
D E. Levy ◽  
E P. Mitchell ◽  
K M. Rowland ◽  
...  
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Metastatic Pancreatic Adenocarcinoma

Retrospective analysis of prognostic and predictive markers in patients with locally advanced unresectable and metastatic pancreatic adenocarcinoma treated with gemcitabine/nabpaclitaxel: Influence of the presence of stent.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 483-483 ◽  
Author(s):  
Ana Fernandez Montes ◽  
Paula Gonzalez Villarroel ◽  
Manuel Valladares Ayerbes ◽  
Juan Cruz De la Cámara Gómez ◽  
Guillermo Quintero ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Weight Loss ◽  
Pancreatic Adenocarcinoma ◽  
Univariate Analysis ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Biliary Stent ◽  
Neutrophil Lymphocyte Ratio ◽  
Risk Of Death ◽  
Metastatic Pancreatic Adenocarcinoma

483 Background: Placement of a biliary stent is a standard measure for patients (pts) with pancreatic cancer. We evaluated prognostic/predictive factors that could predict the benefit of gemcitabine/nabpaclitaxel in pts with locally advanced unresectable and metastatic pancreatic adenocarcinoma and whether the presence of a biliary stent reduced the treatment efficacy Methods: We retrospectively analyzed 39 pts with locally advanced and metastatic pancreatic cancer treated with gemcitabine/nabpaclitaxel. Data included lactate dehydrogenase (LDH) level, alkaline phosphatase, neutrophil/lymphocyte ratio (NLR), performance status (PS), weight loss, presence of stent, analgesics use and CA 19.9 level. The correlation with response rate, progression-free survival (PFS) and overall survival (OS) was analyzed. Objective toxicities were assessed. Results: 30 pts (77%) had metastatic disease and 9 (23%) locally advanced pancreatic cancer. 46% had liver metastases and 41% lung metastases. Mean age of pts: 62 years (62% male). 20% had PS:0, 67% PS:1 and 13% PS:2. Stents were placed in 30% of pts, 69% had weight loss and 64% used analgesics at diagnosis. At the time of analysis 14 pts had died (25 alive). 56% had progressed, 3% were lost to follow-up and 41% had not progressed. A total of 54% disease stabilizations, 21% partial responses and 18% progressions were achieved (deaths: 7%). 43% required dose reduction. The main toxicity was hematologic (grade 1 anemia). Median PFS: 6 months (95%CI 4.4-7.6). Median OS: 15 months (95%CI 10.4-19.6). There was a statistically significant relationship between LDH level, NLR and PS and OS: LDH level higher than 363 increased the risk of death, NLR above 3.1 increased 1.8 times the risk of death and mean OS of pts with ECOG:0,1 was greater than that of pts with ECOG:2. No relationship between the presence of stent and PFS or OS was found, as well as with any of the other variables. Conclusions: The presence of stent did not reduce the efficacy of gemcitabine/nabpaclitaxel. Univariate analysis showed PS as a prognostic factor while multivariate showed LDH and NLR.

Phase 1b/2 trial of cancer stemness inhibitor napabucasin (NAPA) + nab-paclitaxel (nPTX) and gemcitabine (Gem) in metastatic pancreatic adenocarcinoma (mPDAC).

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. 4110-4110 ◽  
Author(s):  
Tanios S. Bekaii-Saab ◽  
Alexander Starodub ◽  
Bassel F. El-Rayes ◽  
Safi Shahda ◽  
Bert H. O'Neil ◽  
...  
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Cancer Stemness ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Phase 1B

scholarly journals Preoperative gemcitabine based chemo-radiotherapy in locally advanced non metastatic pancreatic adenocarcinoma

2009 ◽  
Vol 2 (1) ◽  
pp. 7 ◽  
Author(s):  
Doaa W Maximous ◽  
Mostafa E Abdel-Wanis ◽  
Mohammed I El-Sayed ◽  
Alaa A Abd-Elsayed
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Locally Advanced ◽  
Metastatic Pancreatic Adenocarcinoma
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