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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)

Renewed promise for potential lung cancer vaccine
Source: Lung Cancer News From Medical News Today [2014.03.25]
Researchers at UC Davis have found that the investigational cancer vaccine tecemotide, when administered with the chemotherapeutic cisplatin, boosted immune response and reduced the number of tumors...

Targeted drug 'prolongs survival for cervical cancer patients'
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.03.10]
Cisplatin-based chemoradiation therapy (CRT) is the most common treatment for cervical cancer. But a new study suggests that a targeted drug could increase patient survival.

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)

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

Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer: final results of a randomized, double-blind, placebo-controlled, phase 3 study. [2012]
pemetrexed-cisplatin for SCCHN... CONCLUSIONS: Pemetrexed-cisplatin compared with placebo-cisplatin did not

A phase II randomized study of cisplatin-pemetrexed plus either enzastaurin or placebo in chemonaive patients with advanced non-small cell lung cancer. [2012]
non-small cell lung cancer (NSCLC)... CONCLUSIONS: Enzastaurin and cisplatin-pemetrexed is tolerable with preliminary

Comparison of pemetrexed plus cisplatin with other first-line doublets in advanced non-small cell lung cancer (NSCLC): A combined analysis of three phase 3 trials. [2011.11.22]
INTRODUCTION: In a first-line study of advanced NSCLC, pemetrexed-cisplatin was more effective among patients with adenocarcinoma and large-cell carcinoma compared with gemcitabine-cisplatin (median survival of 11.8 versus 10.4 months, P=.005), while survival with pemetrexed-cisplatin was shorter than with gemcitabine-cisplatin in patients with squamous cell carcinoma. The comparability of pemetrexed-cisplatin to other commonly used regimens within histology subgroups needs to be explored... CONCLUSION: In the absence of randomized clinical trial data comparing pemetrexed-cisplatin to commonly used doublets in advanced NSCLC other than gemcitabine-cisplatin, this combined analysis of multiple trials provides estimates for such comparisons. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.

Docetaxel/cisplatin followed by FOLFIRI versus the reverse sequence in metastatic gastric cancer. [2011.07]
BACKGROUND: Both docetaxel-based and irinotecan-based chemotherapy has been demonstrated as active combination regimen in either first-line or second-line setting for metastatic gastric cancer. The purpose of this trial was to evaluate the two active regimens, docetaxel/cisplatin and FOLFIRI, as first- and second-line chemotherapy and to compare the sequence of the two regimens in terms of efficacy and tolerability... CONCLUSIONS: The ORR, TCR of Arm A (DP --> FOLFIRI) were not different from those of Arm B (FOLFIRI --> DP). There was no statistically significant difference in 1st PFS, 2nd PFS, and OS of both arms. Although the trial was terminated early due to poor patient accrual, we found that both DP and FOLFIRI regimens were tolerable with comparable efficacies regardless of the sequence administered.

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.

Tri-weekly Cisplatin Based Chemoradiation in Locally Advanced Cervical Cancer [Recruiting]
Current standard treatment for locally advanced cervical cancer is cisplatin-based concurrent chemoradiation (CRT). Although recently reported meta-analysis studies also demonstrated improved local control rates and survival with cisplatin-based chemotherapy concurrent to radiation therapy (RT), the optimal cisplatin dose and dosing schedule are still undetermined.

In light of the results of the previous clinical trial, weekly cisplatin 40 mg/m2 considered to be a standard regiment in cisplatin doses and dosing schedules. However, our randomized phase II trial showed that tri-weekly cisplatin 75mg/m2 has lower toxicities and a better outcome in locally advanced cervical cancer.

In this randomized phase III trial, the investigators investigate that there may be a survival difference between weekly cisplatin 40 mg/m2 and tri-weekly cisplatin 75 mg/m2 administration concurrent to RT in cervical cancer.

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.

more trials >>


Page last updated: 2014-03-25

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