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)
Ovarian cancer patients may benefit from nanoparticles designed to deliver three cancer drugs at a time
Source: Cancer / Oncology News From Medical News Today [2014.04.18]
Delivering chemotherapy drugs in nanoparticle form could help reduce side effects by targeting the drugs directly to the tumors.
Irregular Periods May Be Risk Factor for Ovarian Cancer, Study Suggests
Source: MedicineNet Ovarian Cancer Specialty [2014.04.10]
Title: Irregular Periods May Be Risk Factor for Ovarian Cancer, Study Suggests
Category: Health News
Created: 4/9/2014 2:36:00 PM
Last Editorial Review: 4/10/2014 12:00:00 AM
Discovery of 2 genes that modulate risk of breast and ovarian cancer
Source: Breast Cancer News From Medical News Today [2014.04.08]
Today we know that women carrying BCRA1 and BCRA2 gene mutations have a 43% to 88% risk of developing breast cancer before the age of 70.
Additional link found between endometriosis and ovarian cancer
Source: Immune System / Vaccines News From Medical News Today [2014.04.08]
Some women with endometriosis, a chronic inflammatory disease, are predisposed to ovarian cancer, and a genetic screening might someday help reveal which women are most at risk, according to a...
Study published on the relationship between imaging and OVA1® in assessing risk of ovarian cancer
Source: MRI / PET / Ultrasound News From Medical News Today [2014.03.24]
A new study of OVA1® clinical performance, titled "The Effect of Ovarian Imaging on the Clinical Interpretation of a Multivariate Index Assay," has been released as an online advance publication...
Published Studies Related to Paraplatin (Carboplatin)
BEAM: a randomized phase II study evaluating the activity of bevacizumab in
combination with carboplatin plus paclitaxel in patients with previously
untreated advanced melanoma. [2012]
metastatic melanoma... CONCLUSION: The study did not meet the primary objective of statistically
Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. [2011.09.17]
BACKGROUND: Platinum-based doublet chemotherapy is recommended to treat advanced non-small-cell lung cancer (NSCLC) in fit, non-elderly adults, but monotherapy is recommended for patients older than 70 years. We compared a carboplatin and paclitaxel doublet chemotherapy regimen with monotherapy in elderly patients with advanced NSCLC... INTERPRETATION: Despite increased toxic effects, platinum-based doublet chemotherapy was associated with survival benefits compared with vinorelbine or gemcitabine monotherapy in elderly patients with NSCLC. We feel that the current treatment paradigm for these patients should be reconsidered. FUNDING: Intergroupe Francophone de Cancerologie Thoracique, Institut National du Cancer. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Randomized phase II study of pemetrexed, carboplatin, and thoracic radiation with or without cetuximab in patients with locally advanced unresectable non-small-cell lung cancer: Cancer and Leukemia Group B trial 30407. [2011.08.10]
PURPOSE: Cancer and Leukemia Group B conducted a randomized phase II trial to investigate two novel chemotherapy regimens in combination with concurrent thoracic radiation therapy (TRT)... CONCLUSION: The combination of pemetrexed, carboplatin, and TRT met the prespecified criteria for further evaluation. This regimen should be studied further in patients with locally advanced unresectable nonsquamous NSCLC.
Randomized phase III placebo-controlled trial of carboplatin and paclitaxel with or without the vascular disrupting agent vadimezan (ASA404) in advanced non-small-cell lung cancer. [2011.08.01]
PURPOSE: This phase III trial was conducted to test whether the novel vascular disrupting agent ASA404 (vadimezan), when combined with first-line platinum-based chemotherapy, improves survival in patients with advanced non-small-cell lung cancer (NSCLC) versus chemotherapy alone... CONCLUSION: The addition of ASA404 to carboplatin and paclitaxel, although generally well tolerated, failed to improve frontline efficacy in advanced NSCLC.
Decreased hypersensitivity reactions with carboplatin-pegylated liposomal doxorubicin compared to carboplatin-paclitaxel combination: analysis from the GCIG CALYPSO relapsing ovarian cancer trial. [2011.08]
OBJECTIVE: To describe and analyze observed hypersensitivity reactions (HSR) from the randomized, multicenter phase III CALYPSO trial that evaluated the efficacy and safety of the combination of carboplatin and pegylated liposomal doxorubicin (CD) compared with standard carboplatin-paclitaxel (CP) in patients with platinum-sensitive relapsed ovarian cancer (ROC)... CONCLUSIONS: Use of PLD with carboplatin instead of paclitaxel and older age were the only 2 factors predicting a low rate of HSRs in patients with ROC. CD has previously demonstrated superior progression-free survival and therapeutic index than CP. Taken together these data support the use of CD as a safe and effective therapeutic option for platinum-sensitive ROC. Copyright (c) 2011 Elsevier Inc. All rights reserved.
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.
Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer [Recruiting]
Patients who have this kind of cancer are often treated with several drugs. Carboplatin is
one that seems to work for many treatment cycles. Even though it may work against the
cancer, the patient can become allergic to it. If that happens, they would have to stop
taking the drug. The standard way to give carboplatin is by vein over 30 minutes. The
purpose of this study is to:
Find out if giving carboplatin over three hours can prevent the allergy. See if medicine
given before the carboplatin can help reduce the risk of allergic reactions.
Some patients have been given carboplatin over 3 hours instead of 30 minutes. They had fewer
allergies than we expected. We do not know if this was because of the way they got
carboplatin or because of something else.
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.
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: 2014-04-18
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