NABPLAGEM vs. Nab-Paclitaxel/Gemcitabine for Pancreatic Cancer

(PLATINUM-CAN Trial)

Overseen By Erica S Tsang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University Health Network, Toronto

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Cisplatin, Grade 2 neuropathy, active brain metastases, 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: 12 months

10 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain medications. If you are on strong CYP3A4 inhibitors or inducers, you must stop them 14 days before starting the trial.

What data supports the effectiveness of the drug NABPLAGEM for pancreatic cancer?

Research shows that the combination of nab-paclitaxel and gemcitabine increases survival rates in patients with metastatic pancreatic cancer, suggesting it is an effective treatment option. ^{1 2 3 4 5}

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

The combination of nab-paclitaxel and gemcitabine is generally considered safe for treating pancreatic cancer, but it can cause side effects like sepsis (a severe infection) and neutropenia (low white blood cell count), which may require careful management. ^{1 2 3 6 7}

How does the NABPLAGEM treatment for pancreatic cancer differ from other treatments?

NABPLAGEM is a novel treatment being compared to the standard combination of nab-paclitaxel and gemcitabine for pancreatic cancer. While nab-paclitaxel and gemcitabine are already known to improve survival in pancreatic cancer, NABPLAGEM may offer a new approach or combination that could potentially enhance effectiveness or safety, although specific details about NABPLAGEM's unique aspects are not provided in the available research. ^{1 3 8 9 10}

What is the purpose of this trial?

This study will compare two different regimens for patients with BRCA1/2 or PALB2 mutated metastatic pancreatic cancer after progression on first-line FOLFIRINOX.

Research Team

Erica S Tsang, MD

Principal Investigator

Princess Margaret Cancer Centre/University Health Network

Eligibility Criteria

This trial is for individuals with metastatic pancreatic cancer that has a BRCA1/2 or PALB2 mutation, who have already been treated with FOLFIRINOX. Specific details about inclusion and exclusion criteria are not provided.

Inclusion Criteria

My cancer is a type of advanced pancreatic cancer.

Ability to understand and willing to sign a written informed consent document

Not pregnant and not nursing

Exclusion Criteria

I do not have another cancer that could affect this treatment's safety or results.

HIV-infected patients without undetectable viral load

I have hepatitis B or untreated hepatitis C.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NABPLAGEM or Nab-paclitaxel/Gemcitabine regimen on days 1 and 15 of every cycle

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 years

Treatment Details

Interventions

• Cisplatin

Trial Overview The study compares two chemotherapy regimens: NABPLAGEM (a combination of drugs) versus Nab-Paclitaxel/Gemcitabine in patients whose pancreatic cancer has specific genetic mutations and has progressed after initial treatment.

Participant Groups

Group I: Arm 1- NABPLAGEM (Nab-paclitaxel+Cisplatin+Gemcitabine) Experimental Treatment 3 Interventions

Nab-paclitaxel 100 mg/m2 + cisplatin 25 mg/m2 + gemcitabine 800 mg/m2 on days 1 and 15 of every cycle.

Group II: Arm 2 - Nab-paclitaxel+gemcitabine Active Control 2 Interventions

Nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 on days 1 and 15 of every cycle.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

Nabpaclitaxel plus S-1 (AS) significantly improved median time to progression (7.1 months) and overall survival (10.2 months) compared to gemcitabine plus S-1 (GS), indicating AS may be a more effective first-line treatment for metastatic pancreatic cancer based on a study of 38 patients.

While both treatments had similar rates of hematological adverse events, AS was associated with a higher risk of sensory neuropathy, suggesting that while AS is effective, it requires careful monitoring for side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety comparison of nabpaclitaxel plus S-1 and gemcitabine plus S-1 as first-line chemotherapy for metastatic pancreatic cancer. Xu, Y., Guo, X., Fan, Y., et al.[2022]

In a study of patients with resected pancreatic ductal adenocarcinoma (PDAC), adjuvant chemotherapy with nab-paclitaxel plus gemcitabine (AG) significantly improved median disease-free survival (15.8 months) and overall survival (28.3 months) compared to gemcitabine alone (12.2 months and 20.6 months, respectively).

While AG showed better survival outcomes, it also led to a higher incidence of sensory neuropathy (53.3% in AG vs. 23.3% in GEM), indicating a trade-off between efficacy and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant nab-paclitaxel plus gemcitabine vs gemcitabine alone for resected pancreatic ductal adenocarcinoma: A single center experience in China. Yin, ZZ., Zhao, ZM., Tang, WB., et al.[2020]

In a study of 200 pancreatic cancer patients receiving gemcitabine and nanoparticle albumin-bound paclitaxel, treatment suspension occurred in 61% of cases, primarily due to severe neutropenia (grade 3/4) in 83.6% of patients.

Low baseline platelet counts and age over 65 were identified as risk factors for treatment suspension, while initiating treatment with a dose reduction helped prevent severe neutropenia and allowed for better management of the chemotherapy regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of risk factors related to administration suspension and severe neutropenia in gemcitabine and nab-paclitaxel treatment. Saito, Y., Takekuma, Y., Kobayashi, M., et al.[2022]

In a study involving 866 patients with resected pancreatic ductal adenocarcinoma, the combination of nab-paclitaxel and gemcitabine showed a significant improvement in overall survival (OS) compared to gemcitabine alone, with a median OS of 41.8 months versus 37.7 months, respectively.

Although the primary endpoint of disease-free survival (DFS) was not significantly improved with nab-paclitaxel + gemcitabine, the treatment was associated with a higher incidence of grade ≥ 3 adverse events (86% vs. 68% for gemcitabine), indicating a need for careful consideration of safety alongside efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial. Tempero, MA., Pelzer, U., O'Reilly, EM., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety comparison of nabpaclitaxel plus S-1 and gemcitabine plus S-1 as first-line chemotherapy for metastatic pancreatic cancer. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine as first-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma: a randomized study. [2023]

4. 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]

5. Spain pubmed.ncbi.nlm.nih.gov

[Nab-Paclitaxel plus gemcitabine in patients with metastatic pancreatic adenocarcinoma: experience of use]. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Detection of risk factors related to administration suspension and severe neutropenia in gemcitabine and nab-paclitaxel treatment. [2022]

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]

8. Greece pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Phase 1B trial of Nab-paclitaxel plus gemcitabine, capecitabine, and cisplatin (PAXG regimen) in patients with unresectable or borderline resectable pancreatic adenocarcinoma. [2022]

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

Modified gemcitabine plus nab-paclitaxel regimen in advanced pancreatic ductal adenocarcinoma. [2022]