Chemotherapy for Pancreatic Cancer
Recruiting in Palo Alto (17 mi)
+286 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Alliance for Clinical Trials in Oncology
No Placebo Group
Prior Safety Data
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.
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.
12347Will 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 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.
5691113What 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.
89101112Eligibility 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
My initial chemotherapy was changed due to side effects from FOLFIRINOX/NALIRIFOX.
My cancer is a type of advanced pancreatic cancer.
My cancer is linked to a harmful BRCA1/2 or PALB2 gene mutation.
My cancer can be measured by tests.
My cancer progressed after first-line FOLFIRINOX or NALIRIFOX treatment.
My condition worsened while on maintenance PARP inhibitor treatment after FOLFIRINOX/NALIRIFOX.
I have not been treated with cisplatin for my pancreatic cancer.
I am 18 years old or older.
I can take care of myself and perform daily activities.
My kidney function, measured by creatinine levels or clearance, is within the normal range.
I am not pregnant or breastfeeding, and my pregnancy test was negative.
My nerve damage in the hands and feet is mild or moderate.
I am on treatment for hepatitis B and my viral load is undetectable.
My hepatitis C is either cured or undetectable while on treatment.
I am not taking medication that strongly affects liver enzyme activity.
Participant Groups
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.
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
Research locations nearbySelect from list below to view details:
Providence Saint Mary Regional Cancer CenterWalla Walla, WA
Rocky Mountain Cancer Centers-PenroseColorado Springs, CO
Saint Alphonsus Medical Center-OntarioOntario, OR
Providence Queen of The ValleyNapa, CA
More Trial Locations
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Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
National Cancer Institute (NCI)Collaborator
References
In vitro evaluation of platinum, titanium and ruthenium metal complexes in cisplatin-sensitive and -resistant rat ovarian tumors. [2019]The antitumor activity of eight new metal complexes (three platinum, one titanium, four ruthenium derivatives) was investigated in a cisplatin (DDP)--sensitive (O-342) and a DDP-resistant (O-342/DDP) ovarian tumor line using the bilayer soft-agar assay. A continuous exposure set up at logarithmically spaced concentrations was used to test the drugs; to uncover possible pharmacokinetic features, a short-term exposure was additionally included for selected compounds. DDP served as the reference drug. The following compounds were investigated: 18-crown-6-tetracarboxybis-diammineplatinum(II) (CTDP), cis-aminotrismethylenephosphonato-diammine-platinum(II) (ADP), cis-diamminecyclohexano-aminotrismethylenephosphonato-platin um(II) (DAP), diethoxybis(1-phenylbutane-1,3-dionato)titanium(IV) (DBT, budotitane), trans-imidazolium-bisimidazoletetrachlororuthenate(III) (ICR), trans-indazolium-tetrachlorobisindazoleruthenate(III) (IndCR), cis-triazolium-tetrachlorobis-triazoleruthenate(III) (TCR) and trans-pyrazolium-tetrachlorobispyrazoleruthenate(III) (PCR). Of the new metal complexes, CTDP was the most active compound in O-342, resulting in a percentage of control plating efficiency (+/- SE) of 1 +/- 1, 12 +/- 8 and 40 +/- 21 following continuous exposure to 10, 1 and 0.1 microM, respectively, and was thus comparable to DDP at equimolar concentrations. In the resistant line, 10 microM CTDP reduced colony growth to 18% +/- 8%, whereas an equimolar concentration of DDP effected a reduction to 26% +/- 9%. During short-term exposure. CTDP was inferior to DDP, which may be ascribed to the stability of the bis-dicarboxylate platinum ring system. The titanium compound DBT, in contrast, showed promising effects at its highest concentration (100 microM) during short-term exposure in both lines; at this concentration the activity in O-342/DDP was higher than that in O-342 (7% +/- 7% vs 34% +/- 17% of control plating efficiency at 100 microM). All ruthenium complexes showed higher activity in the resistant line O-342/DDP than in the sensitive counterpart. ICR was the most active compound. Following continuous exposure of O-342/DDP cells to 10 microM ICR, colony growth was reduced to 18% +/- 4% that of controls. Further studies should concentrate on CTDP and ICR for the following reasons; the activity of CTDP was equal to that of DDP at equimolar concentrations during continuous exposure; considering that the in vivo toxicity of DDP was 3-fold that of CTDP, an increase in the therapeutic index of CTDP would be expected. ICR showed the best effect of all ruthenium complexes; it was superior to DDP in the resistant line.
Cis-platin-Mecy as salvage chemotherapy in recurrent advanced ovarian carcinoma. [2013]Cis-platin (DDP) has proved to be highly active in the treatment of ovarian adenocarcinoma. The Authors have treated 12 patients with istologically proven advanced ovarian carcinoma with a type of alternating regimen consisting of four weekly DDP courses (1 mg/kg b.w./week) followed by monthly courses high-dose methotrexate (750 mg/mq i.v.) plus cyclophosphamide (250 mg/mq for 5 days) (Mecy). The alternating regimen DDP + Mecy proved to have significant activity as a salvace chemiotherapy regimen for patients with advanced ovarian carcinoma.
Cis-diaminodichloroplatinum (II) chemotherapy for advanced adenocarcinoma of the upper gastrointestinal tract. [2018]A phase II study of cis-diaminodichloroplatinum (II) (cis-DDP) was carried out in 55 patients with advanced adenocarcinoma of the upper gastrointestinal tract. The drug was given at a dose of 100 mg/m2 i.v. over 2h every 3-4 weeks, with hydration and mannitol diuresis. There were 3 partial responses (6%) among 51 evaluable patients (esophagus 12, stomach 16, pancreas 14, liver 6, and biliary 3). Toxicity was moderate with cumulative nephrotoxicity being the most serious side effect. Myelosuppression was noted in 25% of patients, all having had prior therapy with mitomycin C and nitrosoureas. Activity of cis-DDP as a single agent against adenocarcinoma of the upper gastrointestinal tract in our patient population was minimal.
Treatment of ovarian cancer: current status. [2015]Cytoreductive surgery followed by platinum-based combination chemotherapy has been standard therapy for patients with advanced epithelial ovarian cancer. Despite advances in surgery and in the development of a less toxic platinum compound (carboplatin), most patients with advanced ovarian cancer are not cured. Current clinical trials focus on dose-intense chemotherapy, routes and schedules of administration, and the role of paclitaxel (Taxol; Bristol-Myers Squibb Co, Princeton, NJ). This novel agent has been shown to be highly active in patients with platinum-resistant ovarian cancer. Paclitaxel together with platinum (ie, cisplatin or carboplatin) combinations are now being tested in prospective randomized trials and in pilot studies in previously untreated patients with advanced disease.
Gemcitabine or gemcitabine plus cisplatin for in 42 patients with locally advanced or metastatic pancreatic cancer. [2022]A multi-center randomized phase III clinical trial was designed to evaluate the efficacy, clinical benefit response (CBR) and toxicity profile of germcitabine (GEM) or GEM plus cisplatin (CDDP) for locally advanced (LAPC) or metastatic pancreatic cancer (MPC).
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]This phase II study was initiated to determine the activity and toxicity of a combination of gemcitabine (GEM) and cisplatin (CDDP) in patients with pancreatic cancer.
cis-Diammine(pyridine)chloroplatinum(II), a monofunctional platinum(II) antitumor agent: Uptake, structure, function, and prospects. [2021]We have identified unique chemical and biological properties of a cationic monofunctional platinum(II) complex, cis-diammine(pyridine)chloroplatinum(II), cis-[Pt(NH(3))(2)(py)Cl](+) or cDPCP, a coordination compound previously identified to have significant anticancer activity in a mouse tumor model. This compound is an excellent substrate for organic cation transporters 1 and 2, also designated SLC22A1 and SLC22A2, respectively. These transporters are abundantly expressed in human colorectal cancers, where they mediate uptake of oxaliplatin, cis-[Pt(DACH)(oxalate)] (DACH = trans-R,R-1,2-diaminocyclohexane), an FDA-approved first-line therapy for colorectal cancer. Unlike oxaliplatin, however, cDPCP binds DNA monofunctionally, as revealed by an x-ray crystal structure of cis-{Pt(NH(3))(2)(py)}(2+) bound to the N7 atom of a single guanosine residue in a DNA dodecamer duplex. Although the quaternary structure resembles that of B-form DNA, there is a base-pair step to the 5' side of the Pt adduct with abnormally large shift and slide values, features characteristic of cisplatin intrastrand cross-links. cDPCP effectively blocks transcription from DNA templates carrying adducts of the complex, unlike DNA lesions of other monofunctional platinum(II) compounds like {Pt(dien)}(2+). cDPCP-DNA adducts are removed by the nucleotide excision repair apparatus, albeit much less efficiently than bifunctional platinum-DNA intrastrand cross-links. These exceptional characteristics indicate that cDPCP and related complexes merit consideration as therapeutic options for treating colorectal and other cancers bearing appropriate cation transporters.
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.
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.
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.
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).
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.
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).