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.
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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.
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NEWS HIGHLIGHTS
Published Studies Related to Platinol (Cisplatin)
A Phase III Trial of Paclitaxel plus Carboplatin Versus Paclitaxel plus Cisplatin in Stage IVB, Persistent or Recurrent Cervical Cancer: Gynecologic Cancer Study Group/Japan Clinical Oncology Group Study (JCOG0505). [2009.10.12]
A randomized controlled trial has been started in Japan to compare the utility of palliative chemotherapy containing paclitaxel and carboplatin (TC) with paclitaxel and cisplatin (TP) as a standard treatment for patients with the newly diagnosed Stage IVB, persistent or recurrent cervical cancer who are not amenable to curative treatment with local therapy...
Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group study. [2009.10.01]
PURPOSE: Assess toxicity and efficacy of cisplatin (Cis) doublet combinations in advanced and recurrent cervical carcinoma... CONCLUSION: VC, GC, and TC are not superior to PC in terms of overall survival (OS). However, the trend in RR, PFS, and OS favors PC. Differences in chemotherapy scheduling, pre-existing morbidity, and toxicity are important in individualizing therapy.
Cost-Effectiveness of Pemetrexed Plus Cisplatin as First-Line Therapy for Advanced Nonsquamous Non-small Cell Lung Cancer. [2009.09.25]
INTRODUCTION:: To estimate the cost-effectiveness of first-line cisplatin/pemetrexed (Cis/Pem) compared with cisplatin/gemcitabine (Cis/Gem), carboplatin/paclitaxel (Carb/Pac), and carboplatin/paclitaxel/bevacizumab (Carb/Pac/Bev) in patients with advanced non-small cell lung cancer (NSCLC), particularly in those with nonsquamous cell histology (i.e., adenocarcinoma, large cell carcinoma, or histology not otherwise specified)... CONCLUSIONS:: Compared with commonly used and reimbursed regimens for first-line chemotherapy in advanced NSCLC, Cis/Pem may be considered cost-effective, particularly in patients with nonsquamous cell histology. This analysis emphasizes the importance of histology in identifying the appropriate patient for Cis/Pem first-line chemotherapy.
Survival without toxicity for cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemonaive patients with advanced non-small cell lung cancer: a risk-benefit analysis of a large phase III study. [2009.09]
BACKGROUND: In a large phase III study, cisplatin and pemetrexed had non-inferior efficacy and better tolerability compared with cisplatin and gemcitabine in chemonaive patients with non-small cell lung cancer (NSCLC). The current analysis characterised the clinical benefit (i.e. survival) relative to clinical risk (i.e. drug-related toxicity) of the doublets... CONCLUSIONS: Patients with non-squamous NSCLC treated with front-line cisplatin and pemetrexed have superior survival without toxicity (i.e. clinical benefit-to-risk profile) compared with patients treated with cisplatin and gemcitabine.
A randomized controlled trial of transcatheter arterial chemoembolization with lipiodol, doxorubicin and cisplatin versus intravenous doxorubicin for patients with unresectable hepatocellular carcinoma. [2009.09]
Hepatocellular carcinoma (HCC) is a major and often therapeutically frustrating oncological problem. A total of 100 patients with unresectable HCC were recruited and randomized to be treated with either transcatheter arterial chemoembolization (TACE) or systemic chemotherapy... In this setting, serum albumin level is a candidate marker for selection of cases who may benefit from this procedure.
Clinical Trials Related to Platinol (Cisplatin)
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.
Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st-Line Extensive Disease Small Cell Lung Cancer [Completed]
Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st
line Small Cell Lung Cancer
Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix [Active, not recruiting]
The purpose of this study is to compare the effectiveness of two methods of treating cancer of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing radiation therapy, followed by gemcitabine and cisplatin and the other half will receive cisplatin along with radiation therapy
Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC [Completed]
To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or
Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced
or metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.
Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma [Active, not recruiting]
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Page last updated: 2009-10-20
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