WARNING
PARAPLATIN (carboplatin aqueous solution) INJECTION 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 treatment facilities are readily available.
Bone marrow suppression is dose related and may be severe, resulting in infection and/or bleeding. Anemia may be cumulative and may require transfusion support. Vomiting is another frequent drug-related side effect.
Anaphylactic-like reactions to carboplatin have been reported and may occur within minutes of PARAPLATIN administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms.
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PARAPLATIN SUMMARY
PARAPLATIN® (carboplatin lyophilized powder) for INJECTION is supplied as a sterile, lyophilized white powder available in single-dose vials containing 50 mg, 150 mg, and 450 mg of carboplatin for administration by intravenous infusion.
PARAPLATIN® (carboplatin lyophilized powder) is indicated for the following:
Initial Treatment of Advanced Ovarian Carcinoma
PARAPLATIN (carboplatin lyophilized powder) for INJECTION is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of PARAPLATIN and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with PARAPLATIN vs cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES).
There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and longterm survival (≥3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor <2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.
Secondary Treatment of Advanced Ovarian Carcinoma
PARAPLATIN is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin.
Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.
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NEWS HIGHLIGHTSMedia Articles Related to Paraplatin (Carboplatin)
New mouse model finds two genes behind most severe form of ovarian cancer
Source: Cancer / Oncology News From Medical News Today [2015.01.28]
Not all mouse models of ovarian cancer give a true picture of the human disease. Now, a new model of the most severe form may open routes to better treatments and diagnostics.
VolitionRX begins first ovarian cancer detection study to evaluate blood-based test
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.01.22]
VolitionRx Limited, a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, has announced it has signed an agreement to...
Ovarian Cancer Symptoms, Early Warning Signs, and Risk Factors
Source: MedicineNet Ovarian Cancer Specialty [2014.12.01]
Title: Ovarian Cancer Symptoms, Early Warning Signs, and Risk Factors
Category: Doctor's Views
Created: 5/6/2005 12:00:00 AM
Last Editorial Review: 12/1/2014 12:00:00 AM
Ovarian Cancer DNA Detected in Vaginal Fluid, Researchers Report
Source: MedicineNet Ovarian Cancer Specialty [2014.10.08]
Title: Ovarian Cancer DNA Detected in Vaginal Fluid, Researchers Report
Category: Health News
Created: 10/7/2014 12:00:00 AM
Last Editorial Review: 10/8/2014 12:00:00 AM
Ovarian Cancer
Source: MedicineNet altretamine Specialty [2013.09.24]
Title: Ovarian Cancer
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 9/24/2013 12:00:00 AM
Published Studies Related to Paraplatin (Carboplatin)
In vivo intraocular distribution and safety of periocular nanoparticle
carboplatin for treatment of advanced retinoblastoma in humans. [2014]
DESIGN: Prospective, interventional, comparative case series... CONCLUSION: Results may indicate an increased facilitated trans-scleral transport
Weekly AUC2 carboplatin in acquired platinum-resistant ovarian cancer with or
without oral phenoxodiol, a sensitizer of platinum cytotoxicity: the phase III
OVATURE multicenter randomized study. [2014]
potential, when combined with weekly AUC2-carboplatin in PROC patients... CONCLUSIONS: Orally delivered PXD showed no evidence of clinical activity, when
Randomized, phase II, placebo-controlled, double-blind study with and without
enzastaurin in combination with paclitaxel and carboplatin as first-line
treatment followed by maintenance treatment in advanced ovarian cancer. [2013]
diagnosed advanced ovarian cancer... CONCLUSION: The PCE combination increased PFS, but it was not significantly
Phase III trial of carboplatin and paclitaxel with or without sorafenib in
metastatic melanoma. [2013]
metastatic melanoma... CONCLUSION: Sorafenib does not improve OS when given in combination with CP for
A Phase II, randomized, double-blind study of zibotentan (ZD4054) in combination
with carboplatin/paclitaxel versus placebo in combination with
carboplatin/paclitaxel in patients with advanced ovarian cancer sensitive to
platinum-based chemotherapy (AGO-OVAR 2.14). [2013]
xenograft models of human ovarian cancer... CONCLUSIONS: Zibotentan 10mg/day plus carboplatin and paclitaxel did not result
Clinical Trials Related to Paraplatin (Carboplatin)
Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary [Recruiting]
The purpose of this study is to assess efficacy and safety of belinostat in combination with
carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown
primary.
Neoadjuvant Sunitinib With Paclitaxel/Carboplatin in Patients With Triple-Negative Breast Cancer [Recruiting]
This open label, Phase I/II trial is designed to evaluate the combination of sunitinib plus
paclitaxel and carboplatin as neoadjuvant treatment for locally advanced breast cancer. The
Phase I portion of this study will determine the maximum tolerated dose (MTD) of paclitaxel,
sunitinib and carboplatin that can be used together as neoadjuvant treatment in patients
with locally advanced breast cancer. The MTD identified in the Phase I portion of the study
will be used in the Phase II portion which will evaluate the efficacy, safety, and
tolerability of neoadjuvant sunitinib/paclitaxel/carboplatin given for 6 cycles in patients
with locally advanced breast cancer.
Trial Comparing Two Carboplatin Doses in Groups C and D Intraocular Retinoblastoma [Recruiting]
The purpose of this study is to determine whether an increase in the dose of carboplatin in
treatment of advanced intraocular (group C and D) retinoblastoma helps in avoiding
radiotherapy and improves the rate of globe salvage.
Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma [Recruiting]
Based on data demonstrating synergy between paclitaxel and mammalian target of rapamycin
(mTOR) inhibition, the investigators propose that the addition of everolimus to paclitaxel
with carboplatin should lead to improvements in efficacy as measured by progression-free
survival and response rate.
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel [Recruiting]
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436
that can be given in combination with carboplatin and/or Paclitaxel chemotherapy
Reports of Suspected Paraplatin (Carboplatin) Side Effects
Interstitial Lung Disease (7),
OFF Label USE (6),
Gastrointestinal Perforation (4),
Bone Sarcoma (3),
Abdominal Pain Lower (2),
Acute Myeloid Leukaemia (2),
Glioma (1),
Gastrointestinal Necrosis (1),
Acute Monocytic Leukaemia (1),
Disease Progression (1), more >>
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Page last updated: 2015-01-28
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