Radiotherapy + Abraxane for Pancreatic Cancer

Not currently recruiting at 1 trial location

Overseen By Edgar Ben-Josef, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: Distant metastases, Prior abdominal radiation, Others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment combination for pancreatic cancer that cannot be surgically removed. It combines nab-paclitaxel (Abraxane) with high-dose radiation to determine if it can better control the cancer. The study aims to find the safest dose and test whether adding paricalcitol enhances the treatment. Individuals with pancreatic cancer confirmed as unresectable or borderline resectable by specialists may qualify. As a Phase 1 study, the primary focus is on safety and determining the correct dose. Participants have the opportunity to be among the first to receive this novel combination therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that chemotherapy before and/or after the trial may be given as per standard care, which suggests that some medications might be continued. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that nab-paclitaxel, the drug tested in this trial, has been used with other treatments for pancreatic cancer. In some studies, it helped patients live longer and was generally well-tolerated. For example, one study found it safe when combined with other cancer drugs.

Regarding radiation therapy, studies have shown it can effectively control cancer growth. Some types of radiation therapy are well-tolerated, causing only a few severe side effects.

This trial is in its early stages, focusing on finding a safe dose of nab-paclitaxel to use with radiation. Early trials like this are crucial to ensure the treatment does not cause too many side effects. Although earlier studies have shown promising safety data, the specific combination in this trial is still being tested for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of nab-paclitaxel (Abraxane) and radiotherapy for pancreatic cancer because it represents a novel approach that could enhance treatment effectiveness. Nab-paclitaxel is a unique formulation of the chemotherapy drug paclitaxel, designed to be more easily absorbed by the body and potentially deliver more potent cancer-fighting effects. Unlike standard treatments, which typically involve gemcitabine-based chemotherapy, this combination targets cancer with both a powerful chemotherapy agent and precise radiation, potentially improving outcomes for patients with challenging cases like borderline resectable or unresectable pancreatic cancer. By determining the safest and most effective dose levels, researchers hope to provide a more robust therapeutic option for patients facing this aggressive disease.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that nab-paclitaxel, when combined with other treatments, can significantly benefit people with pancreatic cancer. One study found that combining nab-paclitaxel with gemcitabine reduced the risk of disease progression by 31%. Another study reported that 70% of patients experienced a significant decrease in tumor markers, substances that can indicate cancer in the body. Nab-paclitaxel is generally well-tolerated, with most patients not experiencing severe side effects. In this trial, participants will receive nab-paclitaxel alongside radiation therapy. Nab-paclitaxel may increase the sensitivity of cancer cells to radiation, potentially enhancing treatment effectiveness. This combination offers hope for better cancer control and possibly improved survival rates. ^{1 2 6 7 8}

Who Is on the Research Team?

Edgar Ben-Josef, MD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a specific type of pancreatic cancer that can't be removed by surgery or is borderline removable. They should be relatively healthy, able to consent, and willing to use birth control if they can have children. People with spread-out cancer, previous abdominal radiation, other recent cancers, or who are pregnant/nursing cannot join.

Inclusion Criteria

My cancer is a type of pancreatic cancer called adenocarcinoma.

My condition is considered inoperable or nearly inoperable by a team of doctors.

Patients of reproductive potential must agree to use an effective contraceptive method

Exclusion Criteria

Pregnant women, women planning to become pregnant, and nursing women

Treatment with an investigational anti-cancer agent within 4 weeks prior to enrollment

My cancer has spread to distant parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy and Radiation

Nab-paclitaxel dose escalation with concurrent dose-escalated radiation therapy to determine maximum tolerated dose (MTD)

6-8 weeks

Weekly visits for dose escalation monitoring

Chemotherapy and Radiation with Paricalcitol

Evaluation of the addition of paricalcitol to nab-paclitaxel with dose-escalated radiation therapy

6-8 weeks

Weekly visits for monitoring and dose adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• nab-paclitaxel
• Radiotherapy

Trial Overview

The study tests increasing doses of nab-paclitaxel (Abraxane) combined with constant-dose radiation therapy in one part and then combines the best dose found with higher-dose radiation in another part. It aims to see if this combo improves survival and tumor control.

How Is the Trial Designed?

Group I: Subtrial 2- Abraxane 125mg; Borderline get 55cGY, unresectable get 57.5cGY until next escalation Experimental Treatment 2 Interventions

Group II: Subtrial 1-Arm B (Dose Level 2 of Abraxane: 3+4 enrollment) Experimental Treatment 2 Interventions

Determine the maximum dose of Abraxane that is allowable and safe for patients receiving both Abraxane and radiation therapy.

Group III: Subtrial 1-Arm A (Dose Level 1 of Abraxane) Experimental Treatment 2 Interventions

Determine if it is safe or not (via occurrence of dose limiting toxicities) for patients to receive both Abraxane and radiation therapy.

nab-paclitaxel is already approved in United States, European Union for the following indications:

Approved in United States as Abraxane for:

• Metastatic pancreatic adenocarcinoma

Approved in European Union as Abraxane for:

• Metastatic pancreatic adenocarcinoma

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Published Research Related to This Trial

In a phase 1 study involving 9 patients with locally advanced pancreatic cancer, the combination of weekly nab-paclitaxel and daily radiotherapy was found to be safe and well-tolerated, with minimal severe side effects.

After treatment, 4 patients were able to undergo surgical resection with negative margins, indicating a significant treatment effect and limited tumor viability, suggesting potential for improved outcomes in this challenging cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I dose escalation trial of nab-paclitaxel and fixed dose radiation in patients with unresectable or borderline resectable pancreatic cancer. Shabason, JE., Chen, J., Apisarnthanarax, S., 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 phase I trial involving 14 patients with unresectable locally advanced pancreatic cancer, the maximum tolerated dose (MTD) of nab-paclitaxel combined with external beam radiotherapy (EBRT) was determined to be 75 mg/m², as doses above this led to significant toxicities.

The treatment was generally well-tolerated, with common side effects including nausea and fatigue, and resulted in a median progression-free survival of 4.7 months and overall survival of 10.8 months, indicating potential efficacy in this challenging cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Trial of nab-Paclitaxel Administered Concurrently With Radiotherapy in Patients With Locally Advanced Inoperable Pancreatic Adenocarcinoma. Roy, AC., Abbas, MN., Price, TJ., et al.[2023]

Nab-paclitaxel was well tolerated in pediatric solid tumor models, with a maximum weight loss of about 10% that returned to baseline after treatment, indicating a favorable safety profile.

The treatment showed significant efficacy, improving event-free survival in 19 out of 20 solid tumor xenograft models, particularly demonstrating high activity against Ewing sarcoma and rhabdomyosarcoma, making it a promising candidate for further pediatric evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial testing (stage 1) of the tubulin binding agent nanoparticle albumin-bound (nab) paclitaxel (Abraxane(®)) by the Pediatric Preclinical Testing Program (PPTP). Houghton, PJ., Kurmasheva, RT., Kolb, EA., et al.[2022]

In a study of 80 Italian patients with metastatic pancreatic cancer, treatment with nab-paclitaxel in combination with gemcitabine resulted in a median overall survival of 8 months and a median progression-free survival of 5 months, indicating its efficacy.

Nab-paclitaxel was well-tolerated and led to significant pain relief, with reductions in the tumor marker CA 19-9 correlating positively with overall survival, suggesting it may be a useful predictor of treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of nab-paclitaxel in patients with metastatic pancreatic cancer. De Luca, R., Blasi, L., Alù, M., et al.[2022]

Nab-paclitaxel (Abraxane(®)) combined with carboplatin has been approved for treating advanced non-small-cell lung cancer (NSCLC) and showed a significantly improved overall response rate compared to traditional solvent-based paclitaxel in a Phase III trial.

Patients receiving nab-paclitaxel experienced fewer side effects such as neutropenia and neuropathy, making it a safer option, although it was associated with more thrombocytopenia and anemia compared to solvent-based paclitaxel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

nab-paclitaxel for the management of patients with advanced non-small-cell lung cancer. Hirsh, V.[2022]

Nab-paclitaxel (Abraxane) is an effective treatment for metastatic breast cancer, showing a superior therapeutic index compared to conventional paclitaxel in a Phase III study with a standard dose of 260 mg/m² every three weeks.

In patients with poor prognostic factors, nab-paclitaxel demonstrated rapid and significant tumor responses, indicating it may be particularly beneficial for those with more severe disease, and lower doses (100 and 150 mg/m² weekly) also showed promising efficacy, suggesting potential for dose tailoring in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the role of nab-paclitaxel (Abraxane) in women with aggressive metastatic breast cancer. Ciruelos, E., Jackisch, C.[2015]

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