Chemotherapy + TheraBionic for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Ravi K Paluri, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: THERABIONIC INC.

Must not be taking: Calcium channel blockers

Disqualifiers: Brain metastases, Recent malignancy, Infections, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment for patients with advanced pancreatic cancer. The treatment combines two chemotherapy drugs with a device that emits radio waves. The goal is to see if this combination can improve survival rates and control the disease better than standard treatments.

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 or nifedipine before joining. 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 the drug combination of Gemcitabine, Gemzar, Nab paclitaxel, and Abraxane for pancreatic cancer?

Research shows that combining nab-paclitaxel with gemcitabine leads to better tumor response and longer survival in patients with advanced pancreatic cancer compared to using gemcitabine alone.

^{1 2 3 4 5}

Is the combination of chemotherapy drugs nab-paclitaxel and gemcitabine safe for humans?

The combination of nab-paclitaxel (Abraxane) and gemcitabine (Gemzar) has been studied in various trials and is generally considered to have an acceptable safety profile for treating pancreatic cancer and other advanced solid tumors.

^{2 6 7 8 9}

How is the Chemotherapy + TheraBionic treatment for pancreatic cancer different from other treatments?

This treatment combines chemotherapy drugs Gemcitabine and Nab-paclitaxel, which have shown improved survival rates in pancreatic cancer, with TheraBionic, a novel approach that may enhance treatment effectiveness. This combination aims to offer better outcomes than standard chemotherapy alone.

^{1 2 8 10 11}

Eligibility Criteria

This trial is for adults with newly diagnosed, untreated metastatic pancreatic adenocarcinoma. They should be in good physical condition (ECOG 0-1), have measurable tumors, and agree to use two forms of contraception if applicable. Exclusions include prior chemotherapy for metastasis, enrollment in other trials, certain heart medications, uncontrolled illnesses, recent major surgery, brain metastases or a history of severe allergies to the drugs being tested.

Inclusion Criteria

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

Your blood counts, liver and kidney functions need to be within certain limits. If they are too low, you may need a blood transfusion to qualify.

I am 18 years old or older.

Exclusion Criteria

You have had allergic reactions to drugs similar to gemcitabine and nab-paclitaxel.

I haven't had chemotherapy for advanced cancer or specific drugs in the last 6 months, but FOLFIRINOX is okay.

I haven't had cancer in the last 3 years, except for certain skin, cervical, or low-risk prostate cancers.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gemcitabine and nab-paclitaxel therapy in combination with amplitude-modulated radiofrequency electromagnetic fields using the TheraBionic device

6 months

Regular visits for chemotherapy administration and device usage

Follow-up

Participants are monitored for safety, progression-free survival, and overall survival

Up to 1 year

Periodic visits for CT or MRI scans and clinical assessments

Participant Groups

The study examines the effects of standard chemotherapy (gemcitabine and nab-paclitaxel) combined with TheraBionic device treatment on patients with advanced pancreatic cancer. The goal is to assess how this combination influences the disease compared to traditional treatments alone.

Group I: GEM-ABR [Gemcitabine - Abraxane (nab-Paclitaxel)] with 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, NC

Who Is Running the Clinical Trial?

THERABIONIC INC. Lead Sponsor

Wake Forest University Health Sciences Lead Sponsor

Therabionics Collaborator

References

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

Adjuvant nab-paclitaxel plus gemcitabine vs gemcitabine alone for resected pancreatic ductal adenocarcinoma: A single center experience in China. [2020] Nab-paclitaxel plus gemcitabine (AG) has resulted in higher tumor response and survival rates for metastatic or advanced pancreatic ductal adenocarcinoma (PDAC) compared with gemcitabine (GEM) alone.

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

Clinical efficacy of nab-paclitaxel in patients with metastatic pancreatic cancer. [2022] Label="PURPOSE" NlmCategory="OBJECTIVE">Pancreatic carcinoma is the neoplasia with the major mortality, and main standard treatments in this cancer increase survival but do not lead to complete recovery of the patient. The aim of this study was to evaluate the efficacy of Abraxane® (nab-paclitaxel) in Italian patients with metastatic pancreatic cancer (MPC).

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

The Association of Drug-Funding Reimbursement With Survival Outcomes and Use of New Systemic Therapies Among Patients With Advanced Pancreatic Cancer. [2023] Gemcitabine-nab-paclitaxel (GEMNAB) and fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) both improve survival of patients with advanced pancreatic cancer when compared with single-agent gemcitabine in clinical trials.

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

A phase I trial of nab-paclitaxel, gemcitabine, and capecitabine for metastatic pancreatic cancer. [2022] Substantial antitumor activity has previously been demonstrated with the addition of nab-paclitaxel (Abraxane [Celgene, Summit, NJ]), an albumin-bound formulation of paclitaxel, to gemcitabine in patients with advanced pancreatic cancer. Given preclinical evidence of synergy when a fluoropyrimidine is added to gemcitabine plus a taxane in a sequence-specific schedule, we conducted a phase I study to evaluate the combination of nab-paclitaxel, gemcitabine, and capecitabine administered biweekly in patients with metastatic pancreatic adenocarcinoma.

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

Open-label, Phase I Study of Nivolumab Combined with nab-Paclitaxel Plus Gemcitabine in Advanced Pancreatic Cancer. [2022] Label="PURPOSE">Assess safety and efficacy of nivolumab plus nab-paclitaxel and gemcitabine in patients with locally advanced/metastatic pancreatic cancer in a two-part, open-label, phase I trial.

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] Label="LESSONS LEARNED">Itacitinib in combination with nab-paclitaxel plus gemcitabine demonstrated an acceptable safety profile with clinical activity in patients with advanced solid tumors including pancreatic cancer.The results support future studies of itacitinib as a component of combination regimens with other immunologic and targeted small molecule anticancer agents.

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

Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial. [2023] Label="PURPOSE">This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma (ClinicalTrials.gov identifier: NCT01964430).

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

Nursing Implications of Chemotherapy Agents and Their Associated Side Effects in Patients With Pancreatic Cancer. [2017] Survival for patients with advanced (locally advanced unresectable and metastatic disease) pancreatic cancer is very poor; however, several advances in treatment have been made during the past several years. Gemcitabine (Gemzar®)-based regimens, FOLFIRINOX, and nab-paclitaxel (Abraxane®)-based regimens have demonstrated efficacy in patients with advanced pancreatic cancer. Understanding the unique safety profile of each of these regimens is crucial in helping nurses identify symptoms, develop patient education strategies, and ultimately improve outcomes.

9. Greece pubmed.ncbi.nlm.nih.gov

Phase I Study of Nab-Paclitaxel plus Gemcitabine as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer. [2022] The aim of this study was to investigate the safety and feasibility of neoadjuvant nab-paclitaxel plus gemcitabine therapy for patients with borderline resectable pancreatic carcinoma (BRPC).

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

Gemcitabine and Taxane Adjuvant Therapy with Chemoradiation in Resected Pancreatic Cancer: A Novel Strategy for Improved Survival? [2022] Gemcitabine-taxane combination chemotherapy has demonstrated a survival benefit clinically in metastatic pancreatic cancer (PC). The authors present their experience with gemcitabine and docetaxel (gem/tax)-based adjuvant treatment (Rx) after surgery with curative intent.

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

Gemcitabine plus nab-paclitaxel versus FOLFIRINOX for unresected pancreatic cancer: Comparative effectiveness and evaluation of tumor growth in Veterans. [2023] Advanced, unresectable pancreatic cancer is often treated with either gemcitabine plus nab-paclitaxel (Gem/NabP) or FOLFIRINOX, although these regimens have never been compared in a head-to-head trial. In this study, we compared these two regimens using Veterans Administration (VA) data and evaluated the use of a novel tumor growth formula to predict outcomes.