Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma

Brief summary public domain (ClinicalTrials.gov)

This study will evaluate the role of Gemcitabine and Abraxane in the treatment of resectable and borderline-resectable pancreatic cancer by giving the chemotherapy before surgery.

Detailed description public domain (ClinicalTrials.gov)

This current study proposes to conduct a prospective non-randomized open-label phase II trial using Gemcitabine and Abraxane in the neoadjuvant treatment of resectable and borderline-resectable pancreatic cancer. For patients that are low-risk resectable (based on prediction rule) the plan is to administer 2 cycles of Gemcitabine and Abraxane followed by additional systemic therapy or chemotherapy with radiation therapy (chemoRT), followed by surgical resection. For patients who are either borderline-resectable or high-risk resectable (see schema), the plan is to administer 2 cycles of Gemcitabine and Abraxane followed by chemoradiotherapy concurrent with gemcitabine followed by surgical resection. For those without high-risk features, systemic chemotherapy alone will be administered. The primary endpoints will be R0 surgical resection rate, biochemical (CA 19-9), pathologic and radiologic response rates. Secondary endpoints will include progression-free survival (PFS), overall survival (OS), 30-day post-op mortality, toxicity, quality of life, pain control, and correlative molecular exploratory analysis involving pancreatic tumor and stromal SPARC expression levels. The investigators will also assess the patient, tumor, and clinical characteristics that may predict R0 resectability, thus further refining the predictive rule in high-risk patients as defined by Bao and colleagues. The investigators' hypothesis is that by using targeted and risk-adapted chemotherapy or chemoRT, improved R0 surgical resections can be achieved and effective systemic therapy delivered, which will translate to a significant improvement in overall survival in patients with pancreatic adenocarcinoma, compared to published historical controls.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Biochemical Response Rate [4 - 8 weeks after neoadjuvant therapy]. Mean, U/mL (Full Range). Baseline CA19-9: Chemotherapy (n=3): 383 (2 to 1036); Chemotherapy + ChemoRadiotherapy (n=4): 550 (1 to 1833). Pre-Operative CA19-9: Chemotherapy (n=3): 43 (1 to 109); Chemotherapy + ChemoRadiotherapy (n=4): 53 (1 to 141).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Radiographic Response Rate [4 - 8 weeks after neoadjuvant therapy]. Number, participants. Partial Response: Chemotherapy (n=3): 1; Chemotherapy + ChemoRadiotherapy (n=7): 0. Stable Disease: Chemotherapy (n=3): 2; Chemotherapy + ChemoRadiotherapy (n=7): 5. Progressive Disease: Chemotherapy (n=3): 0; Chemotherapy + ChemoRadiotherapy (n=7): 2.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Pathologic Downstaging and Margin Status [At the time of surgery after neoadjuvant therapy]. Number, participants. R0 Resection: Chemotherapy (n=3): 3; Chemotherapy + ChemoRadiotherapy (n=5): 3. R1 Resection: Chemotherapy (n=3): 0; Chemotherapy + ChemoRadiotherapy (n=5): 2.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

90 Day Post-operative Mortality [90 days after surgery]. Number, participants. Number of survival: Chemotherapy (n=3): 3; Chemotherapy + ChemoRadiotherapy (n=5): 5. Number of mortality: Chemotherapy (n=3): 0; Chemotherapy + ChemoRadiotherapy (n=5): 0.