CLINICAL TRIALS PROFILE FOR CISPLATIN

505(b)(2) Clinical Trials for CISPLATIN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT02436707 ↗	Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma	Recruiting	Janssen, LP	Phase 2	2015-05-05	The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
New Combination	NCT02436707 ↗	Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma	Recruiting	Karyopharm Therapeutics Inc	Phase 2	2015-05-05	The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
New Combination	NCT02436707 ↗	Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma	Recruiting	Roche Pharma AG	Phase 2	2015-05-05	The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
New Dosage	NCT00968799 ↗	Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study	Terminated	Cantonal Hospital of St. Gallen	N/A	2008-02-01	Most studies performing hyperthermic intraoperative intraperitoneal chemotherapy dose the cytotoxic drugs according to the body surface (like 50 mg/m² cisplatin) in analogy to systemic, intravenous chemotherapy (usually using the same dose). Although there seems to be a correlation between body surface and blood volume, the pharmacodynamics of drugs dosed by the body surface is still highly variable and thus dosing on the body surface is increasingly considered controversial for systemic administration. For hyperthermic intraoperative intraperitoneal chemotherapy dosing by the body surface makes even less sense, since the aim is the highest possible drug concentration in the peritoneum without undue local and systemic toxicity. Furthermore, most studies using intraoperative chemotherapy vary the volume of the perfusate according to the size of the patient. Since the amount of cytotoxic drug is already fixed by the dosing on the body surface (amount [mg] = dose [mg/m²] x body surface [m²]) the effective concentration (mg/l) in the perfusate can vary considerably between patients. On the other hand pharmacokinetic analyses have shown that reducing the concentration of the cytotoxic drug in the perfusate reduces the efficacy even if the amount of the drug remains the same. In this study the safety of a new dosing regime will be evaluated. The concentration of cisplatin in the perfusate will be held constant independent of body weight or size to achieve the highest effectiveness of the chemotherapy. The primary endpoint is the safety of the treatment. All patients should be able to receive full dose systemic carboplatin chemotherapy after completion the trial treatment.
New Combination	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	Genentech, Inc.	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
New Combination	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	University of Arizona	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
New Combination	NCT00003589 ↗	Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1998-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating advanced non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer.

All Clinical Trials for CISPLATIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001569 ↗	Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis	Completed	National Cancer Institute (NCI)	Phase 1	1997-01-01	Two days prior to planned surgery, paclitaxel is infused IV over 24 hours. Patients will undergo cytoreductive surgery, to debulk tumor. Scope of procedure will vary with each patient, including a spectrum of possible procedures, such as splenectomy, liver resection, pancreatic resection or bowel resection. After cytoreductive surgery, continuous hyperthermic peritoneal perfusion (CHPP) surgery with cisplatin will begin by placing an influx and efflux catheters via abdominal wall. Perfusion rate of cisplatin is 1.5 L/min and the duration is 90 min. Postoperative intraperitoneal chemotherapy will begin 24 hours after CHPP surgery. Dose escalation will proceed after patients at a given dose level receive 3 courses. In order to properly evaluate hematoxicity, a minimum of 3 weeks will be required before dose escalation. MTD is either the dose level immediately below the level at which 2 of 6 patients in a cohort experience nonhematologic dose limiting toxicity (DLT) or when 4 of 6 patients experience hematologic DLT. Two to 4 months after surgery, laparotomy will be conducted to determine response to treatment. If tumor size is decreased, patients will undergo a second treatment course identical to the same techniques and chemotherapy agents.
NCT00001499 ↗	Phase II Neoadjuvant Trial of a Continuous Infusion of Paclitaxel Plus Cisplatin Followed by Chest Radiotherapy for Patients With Stage III Non-Small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1996-03-01	2-Drug Combination Chemotherapy Followed by Radiotherapy. Paclitaxel, TAX, NSC-125973; Cisplatin, CDDP, NSC-119875; followed by chest irradiation using 4-15 MV photons.
NCT00001450 ↗	Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC	Completed	National Cancer Institute (NCI)	Phase 2	1995-09-01	This is a Phase II study of paclitaxel (Taxol R) administered as a 96-hour (4 day) continuous infusion followed by a bolus of cisplatin for previously untreated patients with stage III/IV or relapsed non-small cell lung cancer (NSCLC). The goal of this phase II study is to determine the response rate of this infusional paclitaxel and bolus cisplatin regimen in patients with advanced NSCLC.
NCT00001426 ↗	A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1995-02-03	A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
NCT00001427 ↗	A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin With G-CSF Support in Patients With Advanced Ovarian Cancer Previously Treated With Paclitaxel and Cisplatin	Completed	National Cancer Institute (NCI)	Phase 2	1995-01-01	The objectives of this study are to determine the response rate to 9-AC in patients with advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based chemotherapy regimens.
NCT00001272 ↗	A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients	Completed	National Cancer Institute (NCI)	Phase 1	1991-09-01	This is a Phase I study which addresses the feasibility and toxicity of adding taxol to the two drug combination which now comprises the standard of care in newly diagnosed advanced stage ovarian cancer, cisplatin and cyclophosphamide. These drugs will be given in a dose intensive fashion with the colony-stimulating factor, G-CSF. Newly diagnosed patients with ovarian cancer will be treated with this regimen to determine the optimal dose of this combination. The pharmacokinetics of taxol and cisplatin DNA-adducts will be studied as well.
NCT00002461 ↗	Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Refractory Hodgkin's Disease or Non-Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1988-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy to kill more cancer cells. PURPOSE: This phase II trial is studying giving high-dose chemotherapy followed by bone marrow or peripheral stem cell transplantation to see how well it works in treating patients with refractory Hodgkin's disease or non-Hodgkin's lymphoma.

Clinical Trial Conditions for CISPLATIN

Condition Name

Condition Name for CISPLATIN
Intervention	Trials
Head and Neck Cancer	198
Lung Cancer	175
Non-small Cell Lung Cancer	156
Gastric Cancer	146

Condition MeSH

Condition MeSH for CISPLATIN
Intervention	Trials
Carcinoma	791
Lung Neoplasms	743
Carcinoma, Non-Small-Cell Lung	606
Carcinoma, Squamous Cell	461

Clinical Trial Locations for CISPLATIN

Trials by Country

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−

Trials by Country for CISPLATIN
Location	Trials
Canada	926
Japan	916
Italy	792
France	649
United Kingdom	647

Trials by US State

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−

Trials by US State for CISPLATIN
Location	Trials
New York	586
California	551
Texas	542
Pennsylvania	458
Illinois	450

Clinical Trial Progress for CISPLATIN

Clinical Trial Phase

Clinical Trial Phase for CISPLATIN
Clinical Trial Phase	Trials
Phase 4	53
Phase 3	806
Phase 2/Phase 3	114

Clinical Trial Status

Clinical Trial Status for CISPLATIN
Clinical Trial Phase	Trials
Completed	1508
Recruiting	713
Unknown status	458

Clinical Trial Sponsors for CISPLATIN

Sponsor Name

Sponsor Name for CISPLATIN
Sponsor	Trials
National Cancer Institute (NCI)	650
Merck Sharp & Dohme Corp.	132
Sun Yat-sen University	124

Sponsor Type

Sponsor Type for CISPLATIN
Sponsor	Trials
Other	4935
Industry	1655
NIH	663

Cisplatin: Clinical Trials, Market Analysis, and Projections

Introduction to Cisplatin

Cisplatin is a platinum-based chemotherapy drug widely used in the treatment of various types of cancer, including testicular, ovarian, lung, and bladder cancers. Its efficacy and broad-spectrum activity have made it a cornerstone in oncology treatment protocols.

Clinical Trials and Recent Findings

Head and Neck Cancer Trials

In recent clinical trials, cisplatin has been compared with other treatment options for patients with locally advanced head and neck cancer who are unable to receive cisplatin due to underlying health conditions. A study published in the Lancet Oncology found that cetuximab, a targeted therapy, outperformed durvalumab, an immunotherapy drug, when combined with radiation therapy. However, this study also highlighted the challenges and uncertainties in treating this understudied population, where cisplatin is often the standard but not always feasible[1].

Another clinical trial, NRG-HN009, is currently comparing two schedules of cisplatin administration (every three weeks versus every week) in combination with radiation therapy for patients with advanced head and neck cancer. This study aims to determine if the weekly cisplatin schedule is better tolerated and as effective as the traditional every-three-weeks schedule[4].

Efficacy and Tolerability

Clinical trials have consistently shown that cisplatin is highly effective against solid tumors, particularly in combination with other chemotherapy agents or radiation therapy. However, its use is often limited by side effects such as nephrotoxicity, hearing loss, and peripheral neuropathy. Ongoing research focuses on improving the tolerability and efficacy of cisplatin through innovative formulations and delivery systems, such as nano-formulations and targeted delivery mechanisms[3][5].

Market Analysis

Market Size and Growth

The cisplatin market was valued at USD 14.2 billion in 2023 and is projected to reach USD 25.6 billion by 2031, growing at a CAGR of 8.23%. This growth is driven by the increasing incidence of cancer, particularly lung, testicular, and ovarian cancers, and the continued demand for effective chemotherapy agents[3].

Segment Analysis

The cisplatin market is segmented by application, with significant shares in the treatment of ovarian, testicular, and bladder cancers. Cisplatin is the gold standard for testicular cancer treatment and is frequently used in combination chemotherapy for ovarian and bladder cancers. The market is also segmented geographically, with North America dominating the global share due to high cancer incidence rates and advanced healthcare infrastructure[2][3].

Key Players and Market Dynamics

Major players in the cisplatin market include Teva Pharmaceutical Industries Ltd., Accord Healthcare, Novartis AG, Sun Pharmaceutical Industries Ltd., and Pfizer, Inc. These companies are involved in strategic collaborations, partnerships, and acquisitions to enhance the production and distribution of cisplatin. These efforts include improving drug formulations, conducting clinical trials, and expanding market reach[2][3].

Market Projections

Growing Demand for Chemotherapy Agents

The increasing number of cancer patients and the evolving treatment regimens are driving the demand for chemotherapy agents like cisplatin. The global trend toward personalized medicine and the rise of combination therapies further propel the utilization of cisplatin in oncology settings[3].

Technological Advancements

Advancements in drug delivery systems and formulations are expected to enhance the efficacy and safety profile of cisplatin. Innovations such as nano-formulations and targeted delivery mechanisms are improving the therapeutic index of cisplatin, making it more tolerable for patients and increasing its adoption[3].

Regional Growth

North America is expected to continue dominating the global cisplatin market, followed by Europe and the Asia Pacific region. The growing healthcare infrastructure in developing countries and increasing awareness about cancer will positively impact the industry growth in these regions[2][5].

Challenges and Future Directions

Side Effects and Resistance

Despite its efficacy, cisplatin's use is limited by its side effects, particularly nephrotoxicity. Ongoing research aims to mitigate these side effects through new formulations and delivery systems. Additionally, efforts to circumvent resistance processes and broaden the clinical usefulness of platinum-based drugs, such as the development of carboplatin and oxaliplatin, are ongoing[5].

Clinical Trials and Research

Future clinical trials will focus on optimizing treatment schedules, such as the NRG-HN009 study, and exploring new combinations of cisplatin with other therapeutic agents. Government and institutional funding for cancer research will continue to play a crucial role in driving these efforts[4].

"Cisplatin is a platinum-based drug primarily known for its effectiveness against solid tumors, and its applications are vital in enhancing patient outcomes. As cancer treatment regimens continue to evolve, the demand for chemotherapy agents like cisplatin is witnessing a significant uptick."[3]

Key Takeaways

• Clinical Trials: Ongoing trials compare cisplatin with other treatments and explore optimal administration schedules to improve efficacy and tolerability.
• Market Growth: The cisplatin market is projected to grow significantly, driven by increasing cancer incidence and demand for effective chemotherapy agents.
• Technological Advancements: Innovations in drug delivery systems and formulations are enhancing the safety and efficacy of cisplatin.
• Regional Dynamics: North America dominates the market, but growth is expected in other regions due to improving healthcare infrastructure.
• Challenges: Mitigating side effects and overcoming resistance remain key challenges and areas of ongoing research.

FAQs

What is the current market size of the cisplatin market?

The cisplatin market was valued at USD 14.2 billion in 2023[3].

What is the projected growth rate of the cisplatin market?

The cisplatin market is projected to grow at a CAGR of 8.23% from 2023 to 2031[3].

What are the main applications of cisplatin in cancer treatment?

Cisplatin is primarily used in the treatment of ovarian, testicular, and bladder cancers[3].

What are the major side effects associated with cisplatin?

The major side effects include nephrotoxicity, hearing loss, and peripheral neuropathy[3][5].

Are there ongoing efforts to improve the tolerability of cisplatin?

Yes, ongoing research focuses on improving formulations and delivery systems to mitigate side effects and enhance efficacy[3][5].

Sources

1. National Cancer Institute: "Cetuximab Outperforms Durvalumab for Head and Neck Cancer" - Cancer Currents Blog, December 19, 2024.
2. GlobeNewswire: "Platinum based cancer drugs market size to reach US$1.8 billion by 2026" - March 25, 2020.
3. Verified Market Research: "Cisplatin Market Size, Scope, Growth, Trends and Forecast" - 2023.
4. NRG Oncology: "NRG-HN009: Cisplatin and Radiation for Advanced Head and Neck Cancer" - Clinical Trial.
5. Polaris Market Research: "Platinum Based Cancer Drugs Market Size - Global Industry Report" - 2023.