100 Participants Needed

Chemotherapy for Pancreatic Cancer

Recruiting at 320 trial locations
JC
Overseen ByJamie Crawley, MA
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Alliance for Clinical Trials in Oncology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the body (metastatic) and a known genetic mutation in the BRCA1, BRCA2, or PALB2 gene.

Will I have to stop taking my current medications?

The trial requires that you stop taking any strong CYP3A4 inhibitors or inducers at least 14 days before starting the study treatment. If you're on these medications, you'll need to discontinue them before joining the trial.

What data supports the effectiveness of the drugs used in the chemotherapy for pancreatic cancer trial?

Research shows that gemcitabine combined with nab-paclitaxel improves survival in patients with advanced pancreatic cancer compared to using gemcitabine alone. Additionally, gemcitabine-taxane combinations have shown survival benefits in metastatic pancreatic cancer.12345

What safety data exists for chemotherapy treatments like Gemcitabine, Cisplatin, and Nab-paclitaxel in humans?

Studies have shown that Gemcitabine, Cisplatin, and Nab-paclitaxel are generally well-tolerated in humans, although they can have side effects. It's important for healthcare providers to understand these side effects to help manage them and improve patient care.34678

What makes the chemotherapy treatment for pancreatic cancer unique?

This chemotherapy treatment for pancreatic cancer is unique because it combines cisplatin, gemcitabine, and nab-paclitaxel, which are known to be effective in other cancers like ovarian cancer, where paclitaxel is used for platinum-resistant cases. This combination may offer a novel approach by leveraging the strengths of each drug to potentially improve outcomes in pancreatic cancer.910111213

Eligibility Criteria

This trial is for adults with metastatic pancreatic cancer that has spread and have a BRCA1, BRCA2, or PALB2 gene mutation. They should not have had cisplatin before but may have had gemcitabine and nab-paclitaxel if it was over a year ago. Participants must show disease progression after initial chemotherapy and be recovered from any significant side effects of previous treatments.

Inclusion Criteria

Patients with absolute neutrophil count >= 1,500/mm^3
Patients with total bilirubin =< 2.0 x institutional upper limit of normal
Patients with platelet count >= 100,000/mm^3
See 21 more

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive chemotherapy with nab-paclitaxel, gemcitabine, and cisplatin or nab-paclitaxel and gemcitabine on days 1 and 15 of each 28-day cycle

Up to 12 months
2 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 5 years
Every 3 months for 2 years, then as needed

Treatment Details

Interventions

  • Cisplatin
  • Gemcitabine
  • Nab paclitaxel
Trial Overview The PLATINUM Trial is testing whether adding cisplatin to the standard chemotherapy combo of nab-paclitaxel plus gemcitabine improves outcomes in patients with certain genetic mutations. It's a phase II/III study comparing these two chemo regimens using CT scans, MRI, and biospecimen collection to assess effectiveness.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (nab-paclitaxel, gemcitabine, cisplatin)Experimental Treatment6 Interventions
Patients receive nab-paclitaxel IV over 30-40 minutes, gemcitabine IV over 30-40 minutes, and cisplatin IV over 30-60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.
Group II: Arm II (nab-paclitaxel, gemcitabine)Active Control5 Interventions
Patients receive nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30-40 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma
🇺🇸
Approved in United States as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma
🇨🇦
Approved in Canada as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma
🇯🇵
Approved in Japan as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials
521
Recruited
224,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

A study of 5465 patients with advanced pancreatic cancer in Ontario showed that the introduction of new chemotherapy regimens, GEMNAB and FOLFIRINOX, significantly improved overall survival rates over time, with median survival increasing from 5.6 months to 7.6 months between 2008 and 2018.
FOLFIRINOX was found to provide better overall survival compared to GEMNAB, particularly in younger and healthier patients, while GEMNAB still showed improved survival compared to the older standard treatment, gemcitabine.
The Association of Drug-Funding Reimbursement With Survival Outcomes and Use of New Systemic Therapies Among Patients With Advanced Pancreatic Cancer.Raphael, MJ., Raskin, W., Habbous, S., et al.[2023]
In a study of 58 patients with resectable metastatic pancreatic cancer treated with gemcitabine and docetaxel, the median overall survival was 52 months, with a 5-year survival rate of 49%, indicating a favorable outcome for this treatment approach.
The study found that while 52% of patients experienced significant toxicity (grade 3 or 4), the majority completed their treatment regimen, and the use of chemoradiation after gem/tax was positively associated with improved survival outcomes.
Gemcitabine and Taxane Adjuvant Therapy with Chemoradiation in Resected Pancreatic Cancer: A Novel Strategy for Improved Survival?Kanji, ZS., Edwards, AM., Mandelson, MT., 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.
Clinical efficacy of nab-paclitaxel in patients with metastatic pancreatic cancer.De Luca, R., Blasi, L., Alù, M., et al.[2022]

References

The Association of Drug-Funding Reimbursement With Survival Outcomes and Use of New Systemic Therapies Among Patients With Advanced Pancreatic Cancer. [2023]
Gemcitabine and Taxane Adjuvant Therapy with Chemoradiation in Resected Pancreatic Cancer: A Novel Strategy for Improved Survival? [2022]
Clinical efficacy of nab-paclitaxel in patients with metastatic pancreatic cancer. [2022]
Nursing Implications of Chemotherapy Agents and Their Associated Side Effects in Patients With Pancreatic Cancer. [2017]
A phase I trial of nab-paclitaxel, gemcitabine, and capecitabine for metastatic pancreatic cancer. [2022]
Weekly gemcitabine and cisplatin chemotherapy: a well-tolerated but ineffective chemotherapeutic regimen in advanced pancreatic cancer patients. A report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD). [2022]
Gemcitabine or gemcitabine plus cisplatin for in 42 patients with locally advanced or metastatic pancreatic cancer. [2022]
Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial. [2023]
Treatment of ovarian cancer: current status. [2015]
In vitro evaluation of platinum, titanium and ruthenium metal complexes in cisplatin-sensitive and -resistant rat ovarian tumors. [2019]
Cis-diaminodichloroplatinum (II) chemotherapy for advanced adenocarcinoma of the upper gastrointestinal tract. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
cis-Diammine(pyridine)chloroplatinum(II), a monofunctional platinum(II) antitumor agent: Uptake, structure, function, and prospects. [2021]
Cis-platin-Mecy as salvage chemotherapy in recurrent advanced ovarian carcinoma. [2013]