All patients will receive open label medication at set dosages unless the dosage needs to be adjusted to treat an adverse event or dose toxicity.

Resectable Pancreatic Cancer

Unresectable Pancreatic Cancer

Pancreatic Adenocarcinoma

Neoadjuvant Pancreatic Cancer

Participants will be treated with the regimen prior to having surgery. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization. If CA19-9 is normalized, then participant will be scheduled for surgery and moved to standard of care. If CA19-9 is not normalized then participants will complete another 3 cycles.

Paclitaxel Protein Bound (Abraxane)

HonorHealth Research Institute

Pre-operative Treatment for Patients With Untreated Pancreatic Cancer

A Phase II Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Paricalcitol as Pre-operative Treatment in Patients With Untreated Resectable, Borderline Resectable and Locally Advanced Adenocarcinoma of the Pancreas

Laboratory testing will be used to determine if the CA19-9 value has normalized after 3 cycles of treatment.

Participants will have an MRI completed after 3 cycles to determine if the tumor has responded to treatment. RECIST 1.1 criteria will be used to evaluate response. A confirmatory PET scan may be ordered to confirm complete response.

Participants will be contacted by telephone every 12 weeks until date of death.

IPD will not be shared with outside researchers.

There will be two treatment groups: those who are deemed resectable and those that are deemed borderline resectable and with locally advanced pancreas cancer.

LCL161 (tablets): 600, 1200, or 1800 mg once a week (Day 1, 8, 15) for 3 weeks, every 28 days Gemcitabine IV: 1,000 mg/m2 once a week (Day 1, 8, 15) for 3 weeks, every 28 days nab-paclitaxel IV: 100 or 125 mg/m2 once a week (Day 1, 8, 15) for 3 weeks, every 28 days

Metastatic Pancreatic Cancer

LCL161 (tablets): 300, 600, 1200, or 1800 mg once a week (Day 1, 8, 15) for 3 weeks, every 28 days

LCL161

Gemcitabine IV: 1,000 mg/m2 once a week (Day 1, 8, 15) for 3 weeks, every 28 days

Gemcitabine

nab-paclitaxel IV: 125 mg/m2 once a week (Day 1, 8, 15) for 3 weeks, every 28 days

nab-Paclitaxel

2 Sites

Phase I Trial of LCL161 and Gemcitabine Plus Nab-Paclitaxel in Metastatic Pancreatic Cancer

Phase I Trial of the Proapoptotic Agonist, LCL161, and Gemcitabine Plus Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer

The maximum dose of LCL161 (tablets: 600, 1200, or 1800 mg once a week (Day 1, 8, 15) for 3 weeks, every 28 days) that is tolerated by the patients.

The percentage of patients that have side effects that require dosage of LCL161 to be stopped or reduced.

Number of patients with Complete Response or Partial Response

US Oncology Research

Novartis Pharmaceuticals

Delta Clinical Research, LLC

Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.

Abraxane Plus Cetuximab

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer.

Overall Response Rate (Complete and Partial Response)

To assess the frequency and severity of toxicities associated with this treatment.

Frequency and Severity of Toxicities

Overall Survival and Progression-free Survival in Patients

Overall Study

Chao Family Comprehensive Cancer Center

Head and Neck Cancer

260 mg/m2 IV over 30 minutes every 3 weeks

Abraxane

Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles

Cetuximab

Study of Albumin Bound-Paclitaxel for Treatment of Recurrent or Metastatic Head and Neck Cancer With Cetuximab

A Phase II Study of Albumin Bound-Paclitaxel (AbraxaneTM) for Treatment of Recurrent or Metastatic Head and Neck Cancer With the Addition of Cetuximab (Erbitux) (IMC-225) on Disease Progression

febrile neutropenia/albumin

Pre-operative Treatment for Patients With Untreated Pancreatic Cancer

Phase I Trial of LCL161 and Gemcitabine Plus Nab-Paclitaxel in Metastatic Pancreatic Cancer

Study of Albumin Bound-Paclitaxel for Treatment of Recurrent or Metastatic Head and Neck Cancer With Cetuximab

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