Gemcitabine + Nab-paclitaxel + TheraBionic P1 for Pancreatic Cancer

Overseen By Anthony F Shields, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Barbara Ann Karmanos Cancer Institute

Must not be taking: Calcium channel blockers

Disqualifiers: Brain metastases, Uncontrolled infections, others

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: Unknown

Duration: 6 months

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking calcium channel blockers (medications that affect heart and blood pressure) like amlodipine and nifedipine before enrolling. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of this treatment for pancreatic cancer?

Research shows that combining gemcitabine with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) significantly improves survival in patients with advanced pancreatic cancer compared to using gemcitabine alone. ^{1 2 3 4 5}

Is the combination of Gemcitabine, Nab-paclitaxel, and TheraBionic P1 safe for humans?

The combination of Gemcitabine and Nab-paclitaxel has been studied for pancreatic cancer and is generally considered safe, with manageable side effects like neutropenia (low white blood cell count) and peripheral neuropathy (nerve damage causing tingling or numbness). These side effects were mostly mild and resolved with treatment adjustments. However, there is no specific safety data available for the addition of TheraBionic P1 to this combination. ^{1 2 6 7 8}

What makes the Gemcitabine + Nab-paclitaxel + TheraBionic P1 treatment unique for pancreatic cancer?

This treatment is unique because it combines the standard drugs Gemcitabine and Nab-paclitaxel, which are already known to be effective for pancreatic cancer, with TheraBionic P1, a novel component that may enhance the overall effectiveness of the treatment. The addition of TheraBionic P1 could potentially offer new benefits not seen with the standard drug combination alone. ^{2 3 4 9 10}

What is the purpose of this trial?

The goal of this study is to learn if the combination of nab-paclitaxel, gemcitabine and an Amplitude-Modulated Radiofrequency Electromagnetic Fields device (Therabionic P1) is safe and effective for patients with adenocarcinoma of the pancreas.

Research Team

Anthony F. Shields

Principal Investigator

Barbara Ann Karmanos Cancer Institute

Eligibility Criteria

This trial is for patients with metastatic pancreatic cancer. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and have a diagnosis of adenocarcinoma of the pancreas.

Inclusion Criteria

I agree to use two forms of birth control during and up to 6 months after the study.

If female patient is of childbearing potential must have a negative serum pregnancy test (βhCG) documented up to 48 hrs prior to administration of chemotherapy.

I am over 18 years old.

Exclusion Criteria

I do not have any severe illnesses or social situations that would stop me from following the study rules.

Pregnant women and breastfeeding women are excluded from this study.

My tumor can be surgically removed or is in an advanced local stage.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gemcitabine, nab-paclitaxel, and amplitude-modulated radiofrequency electromagnetic fields using the TheraBionic device

6 months

Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

Treatment Details

Interventions

• Gemcitabine
• Nab-paclitaxel
• TheraBionic P1

Trial Overview The study tests if combining chemotherapy drugs (Gemcitabine and Nab-paclitaxel) with a device called TheraBionic P1, which uses radiofrequency electromagnetic fields, can safely and effectively treat metastatic pancreatic cancer.

Participant Groups

Group I: Gemcitabine/Nab-Paclitaxel plus TheraBionic Device Experimental Treatment 3 Interventions

Metastatic pancreatic cancer patients will be treated with amplitude-modulated radiofrequency electromagnetic fields using TheraBionic device in combination with standard chemotherapy, gemcitabine- nab-paclitaxel. amplitude-modulated radiofrequency electromagnetic fields will be delivered by the TheraBionic device.

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?

Barbara Ann Karmanos Cancer Institute

Lead Sponsor

Trials

166

Recruited

9,300+

Findings from Research

In a small study of 6 women with heavily pretreated HER2-negative metastatic breast cancer, the combination of nab-paclitaxel (nab-P) and bevacizumab (B), with or without gemcitabine (G), showed promising safety and preliminary efficacy, with only one patient experiencing significant toxicity.

Out of the 6 patients, 2 achieved partial responses and 4 had stable disease, indicating that this combination therapy may be effective, warranting further investigation in a formal phase II trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel albumin-bound particles (abraxane) in combination with bevacizumab with or without gemcitabine: early experience at the University of Miami/Braman Family Breast Cancer Institute. Lobo, C., Lopes, G., Silva, O., et al.[2022]

Nab-paclitaxel plus gemcitabine (nab-P/Gem) is an effective first-line treatment for metastatic pancreatic cancer, with median overall survival rates ranging from 8.7 to 13.5 months across various studies involving a diverse patient population.

The combination of nab-P/Gem with additional agents is being actively researched, showing promise for improving outcomes in advanced pancreatic cancer, with median overall survival extending up to 17 months in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

nab-Paclitaxel for the treatment of pancreatic cancer. Kim, G.[2023]

In a phase 3 trial involving 861 patients with metastatic pancreatic cancer, the combination of nab-paclitaxel and gemcitabine significantly improved overall survival (8.5 months) compared to gemcitabine alone (6.7 months), with a hazard ratio for death of 0.72, indicating a 28% reduction in the risk of death.

The combination therapy also resulted in better progression-free survival (5.5 months vs. 3.7 months) and a higher overall response rate (23% vs. 7%), although it was associated with increased rates of adverse events like neutropenia and neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. Von Hoff, DD., Ervin, T., Arena, FP., et al.[2022]

The combination of nab-paclitaxel, gemcitabine, and capecitabine was found to be well tolerated in a phase I study with 15 patients, establishing a maximum-tolerated dose (MTD) but showing only modest antitumor activity in metastatic pancreatic cancer.

Despite the regimen being generally safe, with a low incidence of severe hematologic toxicities, only 14.3% of patients had a partial response, indicating that optimizing dose intensity may be crucial for improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I trial of nab-paclitaxel, gemcitabine, and capecitabine for metastatic pancreatic cancer. Ko, AH., Truong, TG., Kantoff, E., et al.[2022]

In a study involving 221 patients with metastatic pancreatic ductal adenocarcinoma and poor performance status, the combination of NAB-paclitaxel and gemcitabine was found to be well tolerated, with manageable side effects such as anemia and neutropenia.

Both dosing regimens of NAB-paclitaxel (100 mg/m2 and 125 mg/m2) showed similar efficacy, with comparable response rates and median progression-free survival, indicating that this treatment is effective for fragile patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II Trial to Evaluate the Efficacy and Safety of Nanoparticle Albumin-Bound Paclitaxel in Combination With Gemcitabine in Patients With Pancreatic Cancer and an ECOG Performance Status of 2. Macarulla, T., Pazo-Cid, R., Guillén-Ponce, C., et al.[2022]

In a study of 27 elderly Japanese patients (aged ≥ 75) with non-curatively resectable pancreatic cancer, the combination of nanoparticle albumin-bound paclitaxel (nab-PTX) and gemcitabine (GEM) showed a high disease control rate of 92.6%, indicating strong efficacy in managing the disease.

Despite its effectiveness, the treatment was associated with significant adverse effects, including a 51.9% incidence of grade 3 or higher hemotoxicity and a 22% rate of grade ≥ 3 peripheral nerve disorders, highlighting the need for careful monitoring and dose adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer. Hasegawa, R., Okuwaki, K., Kida, M., et al.[2022]

Nab-paclitaxel, when combined with gemcitabine, significantly improves overall survival in adults with metastatic pancreatic cancer, reducing the risk of death by 28% compared to gemcitabine alone, based on a multinational phase III study.

The treatment has a manageable safety profile, with most adverse events being grade 3 or lower, and common side effects like neutropenia and peripheral neuropathy are generally reversible with dose adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Albumin-bound paclitaxel: a review of its use for the first-line combination treatment of metastatic pancreatic cancer. Hoy, SM.[2021]

In a retrospective study of 29 patients with advanced pancreatic carcinoma and elevated bilirubin levels, treatment with nanoparticle albumin-bound paclitaxel and gemcitabine (nab-P/G) was found to be safe, showing no unexpected toxicities.

The median overall survival for patients treated with nab-P/G was 11.7 months, with no significant differences in survival based on bilirubin levels, indicating that nab-P/G is a feasible treatment option for this challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis. Pelzer, U., Wislocka, L., Jühling, A., et al.[2022]

In a study using 10 patient-derived pancreatic cancer xenograft mouse models, the combination of S-1 and nab-paclitaxel showed significantly greater tumor growth inhibition (103.56%) compared to either treatment alone, indicating enhanced antitumor activity.

Biomarkers such as thymidylate synthase, OPRT, and DPD were identified as potential predictors of S-1 efficacy, while HER2 was linked to improved efficacy of nab-paclitaxel, suggesting that these markers could help tailor treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nab-Paclitaxel Plus S-1 Shows Increased Antitumor Activity in Patient-Derived Pancreatic Cancer Xenograft Mouse Models. Li, JA., Xu, XF., Han, X., et al.[2017]

References

1. France pubmed.ncbi.nlm.nih.gov

Paclitaxel albumin-bound particles (abraxane) in combination with bevacizumab with or without gemcitabine: early experience at the University of Miami/Braman Family Breast Cancer Institute. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

nab-Paclitaxel for the treatment of pancreatic cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

A phase I trial of nab-paclitaxel, gemcitabine, and capecitabine for metastatic pancreatic cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Phase I/II Trial to Evaluate the Efficacy and Safety of Nanoparticle Albumin-Bound Paclitaxel in Combination With Gemcitabine in Patients With Pancreatic Cancer and an ECOG Performance Status of 2. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Albumin-bound paclitaxel: a review of its use for the first-line combination treatment of metastatic pancreatic cancer. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Nab-Paclitaxel Plus S-1 Shows Increased Antitumor Activity in Patient-Derived Pancreatic Cancer Xenograft Mouse Models. [2017]

10. Greece pubmed.ncbi.nlm.nih.gov

Feasibility of Combination Therapy with Nab-paclitaxel Plus Gemcitabine in Patients with Recurrent Pancreatic Cancer. [2022]