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

Trial Summary

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 data supports the effectiveness of the treatment NovoTTF-200T(P) + Chemotherapy for Pancreatic Cancer?

Research shows that the combination of nab-paclitaxel (Abraxane) and gemcitabine is effective as a first-line treatment for metastatic pancreatic cancer, improving overall survival and response rates compared to gemcitabine alone. This combination is well-tolerated and has become a standard treatment for this condition. ^{1 2 3 4 5}

Is the combination of NovoTTF-200T, nab-paclitaxel, and gemcitabine safe for treating pancreatic cancer?

The combination of nab-paclitaxel and gemcitabine has been shown to have an acceptable safety profile in patients with advanced pancreatic cancer, with manageable side effects that can be addressed with dose adjustments. Gemcitabine is generally well tolerated and can be safely administered on an outpatient basis. ^{1 3 4 6 7}

What makes the NovoTTF-200T(P) + Chemotherapy treatment unique for pancreatic cancer?

This treatment is unique because it combines standard chemotherapy drugs, gemcitabine and nab-paclitaxel, with NovoTTF-200T, a device that uses electric fields to disrupt cancer cell division, offering a novel approach compared to traditional drug-only therapies. ^{2 3 4 8 9}

What is the purpose of this trial?

This is a single arm phase II study. All patients will receive 3 cycles of the treatment of nab-paclitaxel (Days 1, 8 and 15), gemcitabine (Days 1, 8 and 15), and TTFields (worn every day for at least 18 hours). Following the initial 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment, patients will undergo restaging by CT or MRI. Patients with stable disease or better will undergo surgery for resection within 8 weeks following completion of initial chemotherapy although enrolling sites are encouraged to perform resection within 4 weeks of Cycle 3 D15 of therapy. If resection yields R0 or R1, patients will begin an additional 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment within 8 weeks of surgery. Based on available literature, it is expected that a percentage of patients will not undergo resection either due to disease progression or due to toxicities/ complications of the neoadjuvant segment of therapy. These patients will be included in the evaluable patients for both co-primary endpoints as well as the secondary endpoints including ORR, adverse events, and OS.

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

Eligibility Criteria

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.

I do not have any severe health conditions that could increase my risk during the trial.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

The nab-paclitaxel/gemcitabine regimen for patients with refractory advanced pancreatic adenocarcinoma. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

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

3. Greece pubmed.ncbi.nlm.nih.gov

First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice. [2022]

4. United States 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. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

[A Case of Gemcitabine and Nab-Paclitaxel Therapy for Multiple Metastatic Pancreatic Cancer]. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors. [2022]

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

New agents in gastrointestinal malignancies: Part 2: Gemcitabine in clinical practice. [2022]

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

Irinotecan plus raltitrexed vs raltitrexed alone in patients with gemcitabine-pretreated advanced pancreatic adenocarcinoma. [2022]

9. Japan 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). [2023]