Nab-paclitaxel + Gemcitabine for Pancreatic Cancer

Recruiting at 3 trial locations

Overseen By Chalaunda Scott

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Academic Thoracic Oncology Medical Investigators Consortium

Must not be taking: Full dose warfarin

Disqualifiers: Unresectable PDAC, Metastatic PDAC, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to estimate the R0 resection rate in patients with Resectable Pancreatic Ductal Adenocarcinoma (R-PDAC) as well as those with Resectable Pancreatic Ductal Adenocarcinoma (BR-PDAC) independently in response to neoadjuvant sequential therapy of combination nab-paclitaxel and gemcitabine followed by stereotactic body radiotherapy (SBRT).

Who Is on the Research Team?

Wells Messersmith

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

Adults over 18 with resectable or borderline-resectable pancreatic cancer, without distant metastasis. They must have good performance status, adequate organ function, no prior treatments for pancreatic cancer, and agree to use contraception. Excludes those with unresectable or metastatic disease, recent major surgery, significant heart issues, uncontrolled infections or gastrointestinal disorders.

Inclusion Criteria

My nerve damage in hands/feet is mild or none.

My cancer has not spread to distant parts of my body.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

External biliary drains

Participation in any investigational drug study within 4 weeks preceding the start of study treatment

I do not have any serious infections needing antibiotics.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive 3 cycles of neoadjuvant combination chemotherapy of nab-paclitaxel and gemcitabine

12 weeks

Regular visits for chemotherapy administration

Re-staging and SBRT

Re-staging CT scan followed by stereotactic body radiotherapy (SBRT) if no metastatic disease is present

4 weeks

1 visit for re-staging CT, multiple visits for SBRT

Surgical Resection

Definitive surgical resection of the tumor

1 week

1 visit for surgery

Adjuvant Chemotherapy

Participants receive 3 cycles of adjuvant combination chemotherapy of nab-paclitaxel and gemcitabine

12 weeks

Regular visits for chemotherapy administration

Follow-up

Participants are monitored for safety and effectiveness after treatment with surveillance CT scans at 3-month intervals

Up to 74 months

Surveillance CT scans every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Gemcitabine
• Nab-paclitaxel

Trial Overview The trial tests a combination of nab-paclitaxel and gemcitabine chemotherapy followed by stereotactic body radiotherapy (SBRT) on patients with operable pancreatic tumors. It aims to determine the success rate of complete tumor removal without microscopic residual disease in two patient groups: R-PDAC and BR-PDAC.

How Is the Trial Designed?

Group I: Nab-paclitaxel and Gemcitabine for R-PDAC Experimental Treatment 2 Interventions

Nab-paclitaxel and gemcitabine, for R-PDAC patients enrolled in this trial, will be given in combination as neoadjuvant combination chemotherapy, followed by SBRT. This is will be followed up by surgical resection and an additional combination chemotherapy of nab-paclitaxel and gemcitabine as adjuvant chemotherapy.

Group II: Nab-paclitaxel and Gemcitabine for BR-PDAC Experimental Treatment 2 Interventions

Nab-paclitaxel and gemcitabine, for BR-PDAC patients enrolled in this trial, will be given in combination as neoadjuvant combination chemotherapy, followed by SBRT. This is will be followed up by surgical resection and an additional combination chemotherapy of nab-paclitaxel and gemcitabine as adjuvant chemotherapy.

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in United States as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Canada as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Japan as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Who Is Running the Clinical Trial?

Academic Thoracic Oncology Medical Investigators Consortium

Lead Sponsor

Trials

5

Recruited

190+

Celgene Corporation

Industry Sponsor

Trials

446

Recruited

58,500+

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University

Criterium, Inc.

Industry Sponsor

Trials

18

Recruited

730+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+