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Platinol (Cisplatin) - Summary

 
 



WARNING

PLATINOL (cisplatin for injection, USP) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

Cumulative renal toxicity associated with PLATINOL is severe. Other major dose-related toxicities are myelosuppression, nausea, and vomiting.

Ototoxicity, which may be more pronounced in children, and is manifested by tinnitus, and/or loss of high frequency hearing and occasionally deafness, is significant.

Anaphylactic-like reactions to PLATINOL have been reported. Facial edema, bronchoconstriction, tachycardia, and hypotension may occur within minutes of PLATINOL administration. Epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms (see WARNINGS and ADVERSE REACTIONS).

Exercise caution to prevent inadvertent PLATINOL overdose. Doses greater than 100 mg/m2/cycle once every 3 to 4 weeks are rarely used. Care must be taken to avoid inadvertent PLATINOL overdose due to confusion with PARAPLATIN® (carboplatin) or prescribing practices that fail to differentiate daily doses from total dose per cycle.

 

PLATINOL SUMMARY

PLATINOL®
(cisplatin for injection, USP)

PLATINOL® (cisplatin for injection, USP) is a white to light yellow lyophilized powder. Each vial of PLATINOL contains 50 mg cisplatin, 450 mg Sodium Chloride, USP, and 500 mg Mannitol, USP.

PLATINOL (cisplatin for injection, USP) is indicated as therapy to be employed as follows:

Metastatic Testicular Tumors

In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures.

Metastatic Ovarian Tumors

In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of PLATINOL and CYTOXAN® (cyclophosphamide). PLATINOL, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received PLATINOL therapy.

Advanced Bladder Cancer

PLATINOL is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy.


See all Platinol indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Platinol (Cisplatin)

Lung Cancer: Expanded Alimta Label
Source: MedPage Today Product Alert [2012.10.19]
WASHINGTON -- The FDA has expanded the indication for the cancer drug pemetrexed injection to act as a maintenance therapy with cisplatin for nonsquamous non-small cell lung cancer.

more news >>

Published Studies Related to Platinol (Cisplatin)

The protective effect of theophyline in cisplatin nephrotoxicity. [2014]
Cisplatin is a potent and a major anti-neoplastic drug in the treatment of a broad spectrum of malignancies. However, its clinical use is limited by renal tubular dysfunction that occurs in a significant percent of patients...

Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial. [2014]
(HEC) in Asian countries... CONCLUSIONS: The addition of aprepitant to standard antiemetic treatment regimens

Protective effect of selenium on cisplatin induced nephrotoxicity: A double-blind controlled randomized clinical trial. [2013]
BACKGROUND: Renal injury is common following cisplatin infusion... Conclusions :selenium could probably prevent cisplatin-induced acute kidney injury, when it is added to hydration therapy in cancerous patients.

Pemetrexed in combination with cisplatin versus cisplatin monotherapy in East Asian patients with recurrent or metastatic head and neck cancer: Results of an exploratory subgroup analysis of a phase III trial. [2013]
trial was conducted to assess efficacy and safety trends based on ethnicity... CONCLUSION: Consistent with findings in the global population,

Randomized, double-blind, placebo-controlled, phase III cross-over study evaluating the oral neurokinin-1 antagonist aprepitant in combination with a 5HT3 receptor antagonist and dexamethasone in patients with germ cell tumors receiving 5-day cisplatin combination chemotherapy regimens: a hoosier oncology group study. [2012]
of cisplatin combination chemotherapy for testicular cancer... CONCLUSION: There was a significant improvement in CR rate with aprepitant

more studies >>

Clinical Trials Related to Platinol (Cisplatin)

Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer [Not yet recruiting]
The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.

A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC [Active, not recruiting]
To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic irradiation.

Study of CBP501 + Pemetrexed + Cisplatin in Patients With Solid Tumors (Phase I) and Patients With Malignant Pleural Mesothelioma (Phase II) [Recruiting]
The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or would otherwise be eligible for cisplatin and pemetrexed as first-line therapy. The maximum tolerated dose (MTD) will be determined based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet combination will be assessed during the phase I part of the trial.

The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at the MTD determined in the phase I part) in previously untreated, unresectable malignant pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be stratified according to histology and performance status.

Dose Reduced Radiotherapy (63,3 Gy) With Paclitaxel/Cisplatin Versus Standard Radiotherapy (70,2 Gy) With 5-Fluorouracil/Cisplatin in Locally Advanced Head and Neck Cancer (Stages III and IV A-B) [Recruiting]
Standard treatment for patients with advanced, unresectable head and neck cancer is a platin-based simultaneous radiochemotherapy (RCT) (Pignon JP et al., Lancet 2000;355: 949-955). However, irradiation dose is still debatable regarding local tumor control and late toxicity. Moreover, it is still unclear which combination of different drugs might be more effective. In recent years, new drugs have been introduced in the field of head and neck cancer. The Taxanes, namely Docetaxel and Paclitaxel, have been investigated in several phase I/II-studies, and showed promising results concerning locoregional control rates and survival data. The RTOG 97-03 trial (Garden et al., J Clin Oncol 2004; 22: 2856-64) compared a RCT either with Cisplatin/5-FU or Cisplatin/Paclitaxel. In this phase II-study an improvement of local tumor control and disease free survival of 15-20% in favour of the Cisplatin/Paclitaxel treatment arm was seen. Therefore, our phase III-trial compares a standard RCT (70. 6 Gy) with Cisplatin/5-FU to a RCT with Cisplatin/Paclitaxel and reduced irradiation dose (63. 6 Gy). Primary endpoint is to proof superiority of the experimental Cisplatin/Paclitaxel treatment arm concerning disease-free-survival. Secondary endpoints are locoregional tumor control, overall survival and quality of life.

Cisplatin, Temozolomide, Abraxane, With Interleukin-2 and Interferon for Metastatic Melanoma [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given in combination with cisplatin, Temodar (temozolomide), interferon alfa-2b, and interleukin-2 (IL-2) to patients with metastatic melanoma.

Primary Objective:

- The primary objective of the Phase I is to determine the toxicity, safety and the

maximum tolerated dose maximum tolerated dose of Abraxane in combination with Cisplatin, Temozolomide, interleukin-2 and interferon a2b in patients with metastatic melanoma.

Secondary Objectives:

- To assess responses to the combination.

- To evaluate the duration of response and the overall survival.

- To determine the effectiveness in delaying the appearance of Central Nervous System

disease.

more trials >>


Page last updated: 2014-12-01

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