NovoTTF-200T(P) + Chemotherapy for Pancreatic Cancer

Overseen By Ahran Lee

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ashish Manne

Disqualifiers: Metastasis, Electrical implants, Cardiovascular, 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: 3

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach for pancreatic cancer using a combination of chemotherapy drugs (gemcitabine and nab-paclitaxel) and a device called NovoTTF-200T, which delivers electric fields to the tumor. The goal is to determine if this combination can improve outcomes for patients with pancreatic adenocarcinoma, a type of cancer that starts in the pancreas. Participants will receive this treatment for three cycles. If their disease remains stable or improves, they may undergo surgery, followed by additional therapy cycles. This trial seeks participants diagnosed with pancreatic cancer that has not spread and who have not yet received other treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in pancreatic cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does mention that patients must not have received prior treatments for pancreatic cancer, which might imply some restrictions. It's best to discuss your specific medications with the trial team.

What prior data suggests that NovoTTF-200T is safe for treating pancreatic cancer?

Research has shown that the combination of NovoTTF-200T, nab-paclitaxel, and gemcitabine is generally safe for people with pancreatic cancer. NovoTTF-200T, a device used to treat other types of cancer, usually does not cause widespread side effects like nausea or fatigue, though some patients might experience skin irritation. Nab-paclitaxel, used with gemcitabine, can help improve survival rates but may cause more side effects in some patients. Gemcitabine, a well-researched drug often used with other treatments for pancreatic cancer, can improve survival rates when combined with other drugs, though it can have common side effects like most chemotherapy drugs. Overall, studies suggest this combination treatment is generally well-tolerated, but patients may still experience side effects from each component. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for pancreatic cancer?

Researchers are excited about NovoTTF-200T combined with chemotherapy for pancreatic cancer because it introduces a novel approach using Tumor Treating Fields (TTFields). Unlike traditional treatments like surgery, radiation, or chemotherapy alone, TTFields use electric fields to disrupt cancer cell division, potentially enhancing the effectiveness of chemotherapy drugs like gemcitabine and nab-paclitaxel. This innovative mechanism offers a non-invasive way to target cancer cells, potentially improving outcomes for patients with this aggressive cancer type.

What evidence suggests that NovoTTF-200T(P) combined with chemotherapy might be an effective treatment for pancreatic cancer?

Research shows that using NovoTTF-200T with chemotherapy can help treat pancreatic cancer. In this trial, participants in the investigational group will receive a combination of NovoTTF-200T, gemcitabine, and nab-paclitaxel. Studies have found that adding NovoTTF-200T to gemcitabine and nab-paclitaxel improves overall survival, reduces pain, and delays cancer spread compared to chemotherapy alone. Nab-paclitaxel, when combined with gemcitabine, lowers the risk of disease progression or death by 31%. Gemcitabine alone has shown good results with few side effects in patients with advanced pancreatic cancer. Together, these treatments offer a hopeful option for people with pancreatic cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Ashish Manne, MD

Principal Investigator

The Ohio State University Comprehensive Cancer Center- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

Are You a Good Fit for This Trial?

This trial is for adults with resectable pancreatic adenocarcinoma who haven't had prior treatments. They must have a Karnofsky Performance Status of at least 70%, no distant metastasis, and adequate organ function. Women of childbearing potential and men must agree to use contraception.

Inclusion Criteria

I am mostly independent and can care for myself.

I am HIV-positive, on effective treatment, and my viral load is undetectable.

My hepatitis B is under control, or I was treated and cured of hepatitis C.

Exclusion Criteria

Pregnant or breastfeeding.

My cancer has spread to distant parts of my body.

Known allergy to medical adhesives or conductive hydrogel.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive 3 cycles of nab-paclitaxel, gemcitabine, and TTFields treatment

12 weeks

3 visits (in-person) per cycle

Surgery and Restaging

Patients with stable disease or better undergo surgery for resection within 8 weeks following completion of initial chemotherapy

4-8 weeks

Adjuvant Treatment

Patients receive an additional 3 cycles of nab-paclitaxel, gemcitabine, and TTFields treatment if resection yields R0 or R1

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Gemcitabine
• Nab paclitaxel
• NovoTTF-200T

Trial Overview The study tests NovoTTF-200T(P) combined with chemotherapy drugs Gemcitabine and Nab-Paclitaxel in patients with pancreatic cancer. Participants will receive this combination before and after surgery if the tumor can be removed.

How Is the Trial Designed?

Group I: Investigational Group Experimental Treatment 3 Interventions

Nab-paclitaxel + gemcitabine + NovoTTF-200T(P) for 3 cycles (28 day cycles) Participants who have stable disease or better after the first 3 cycles of treatment will undergo pancreatectomy within 8 weeks of receiving treatment. If the surgery yields R0 or R1 then patient will receive another 3 cycles of treatment regimen (within 8 weeks of surgery). Those who do not undergo surgery will still be included in the evaluable patients for the objectives

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?

Ashish Manne

Lead Sponsor

Trials

1

Recruited

40+

NovoCure GmbH

Industry Sponsor

Trials

16

Recruited

3,700+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

A retrospective analysis of 59 patients with advanced refractory pancreatic cancer showed that the combination of nab-paclitaxel and gemcitabine (AG) is active as a second-line or beyond treatment, with 10% achieving a partial response and 47% having stable disease.

The median overall survival was 3.9 months and progression-free survival was 3 months, with toxicity levels similar to those reported in the earlier MPACT trial, indicating that AG has manageable side effects in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nab-paclitaxel/gemcitabine regimen for patients with refractory advanced pancreatic adenocarcinoma. Palacio, S., Hosein, PJ., Reis, I., et al.[2020]

Gemcitabine hydrochloride is an effective chemotherapy agent for advanced pancreatic cancer, demonstrating good tolerability and the ability to be administered safely on an outpatient basis.

The side effects associated with gemcitabine are manageable with proper monitoring and can be reversed through dose adjustments, highlighting the importance of oncology nurses in patient education and symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New agents in gastrointestinal malignancies: Part 2: Gemcitabine in clinical practice. Stucky-Marshall, L.[2022]

In a phase II trial involving 61 patients with borderline resectable pancreatic cancer, the neoadjuvant therapy of nab-paclitaxel plus gemcitabine resulted in a median overall survival of 25.2 months and a median recurrence-free survival of 12.3 months, indicating promising efficacy.

The treatment had a high resection rate of 73.8% and an R0 resection rate of 63.9%, but it also presented significant safety concerns, with 73.8% of patients experiencing grade 3/4 adverse events, highlighting the need for careful patient selection, especially for those with prior lung issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of neoadjuvant nab-paclitaxel plus gemcitabine therapy in patients with borderline resectable pancreatic cancer: A multicenter single-arm phase II study (NAC-GA trial). Okada, KI., Kimura, K., Yamashita, YI., et al.[2023]

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]

The combination of nab-paclitaxel and gemcitabine is an effective first-line treatment for metastatic pancreatic cancer, significantly improving overall survival as demonstrated in the phase III trial (MPACT).

In this case study of a 64-year-old man with recurrent pancreatic cancer, the treatment was generally well-tolerated, although he experienced Grade 3 neutropenia, leading to missed doses; he ultimately passed away 9 months after starting chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A Case of Gemcitabine and Nab-Paclitaxel Therapy for Multiple Metastatic Pancreatic Cancer]. Takashima, Y., Shibamoto, J., Kawamura, Y., et al.[2022]

In a phase II study involving 38 patients with advanced pancreatic cancer who had previously failed gemcitabine treatment, the combination of raltitrexed and irinotecan showed a significant objective response rate of 16%, compared to no responses in the raltitrexed-only group.

The combination therapy also demonstrated superior progression-free survival (4.0 months vs 2.5 months) and overall survival (6.5 months vs 4.3 months) compared to raltitrexed alone, with manageable side effects, indicating it could be a promising second-line treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irinotecan plus raltitrexed vs raltitrexed alone in patients with gemcitabine-pretreated advanced pancreatic adenocarcinoma. Ulrich-Pur, H., Raderer, M., Verena Kornek, G., et al.[2022]

The combination of nab-paclitaxel and gemcitabine is a safe and effective first-line chemotherapy for patients with metastatic pancreatic cancer, as demonstrated in a clinical practice setting with four patients.

Despite some patients having elevated bilirubin levels and significant comorbidities, the treatment was well tolerated, leading to clinical remission or disease stabilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice. Vogel, A., Pelzer, U., Salah-Eddin, AB., et al.[2022]

In the phase 3 MPACT trial, nab-paclitaxel plus gemcitabine showed significantly greater reductions in both primary pancreatic tumors and metastatic lesions compared to gemcitabine alone, indicating its efficacy in treating metastatic pancreatic cancer.

The study found that baseline pancreatic tumor burden was a strong predictor of overall survival, and both treatment regimens resulted in consistent tumor shrinkage over time, highlighting the potential of nab-paclitaxel plus gemcitabine for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor Reduction in Primary and Metastatic Pancreatic Cancer Lesions With nab-Paclitaxel and Gemcitabine: An Exploratory Analysis From a Phase 3 Study. Kunzmann, V., Ramanathan, RK., Goldstein, D., et al.[2022]

Itacitinib, a selective JAK1 inhibitor, combined with nab-paclitaxel and gemcitabine, showed an acceptable safety profile and clinical activity in patients with advanced solid tumors, including pancreatic cancer, with a 24% overall response rate across various doses.

The study indicated that while itacitinib was tolerated at lower doses, treatment-related toxicities such as neutropenia and fatigue were common, leading to dose adjustments; however, the study was terminated early due to negative results from a related phase III trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors. Beatty, GL., Shahda, S., Beck, T., et al.[2022]

Citations

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Improvements in Survival and Clinical Benefit With ... The survival rate at 12 months was 18% for gemcitabine patients and 2% for 5-FU patients. Treatment was well tolerated. Conclusion. This study ...

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The efficacy and safety of gemcitabine-based combination ... Our study supported that GEM-based combination therapy was more beneficial to improve patient's survival than GEM alone, while there was no additional benefits ...

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Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as ... This randomized clinical trial examines 5-year outcomes and prognostic factors for overall survival for treatment with modified FOLFIRINOX ...

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The clinical outcomes of adjuvant gemcitabine plus S-1 in ... The 2-year survival rate was 27.3% in the gemcitabine monotherapy group, compared to 67.3% in the GS combination group in the Stage II and III ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5518857/

Efficacy and safety of gemcitabine plus S-1 in pancreatic ... There were 738 (95.8%) overall survival events. In patients with LAPC (n=193), the median survival was 11.83 months for gemcitabine and 16.41 months for GS ( ...