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 'ecosystem' test strongly predicts ovarian cancer survival
Source: IT / Internet / E-mail News From Medical News Today [2016.09.20]
Assessing the cell 'ecosystems' at sites where ovarian cancer has spread round the body strongly predicts the chances of surviving from the disease, a new study reports.
High-calcium, low-lactose diet may reduce risk of ovarian cancer in African-American women
Source: Nutrition / Diet News From Medical News Today [2016.09.20]
Research from Rutgers Cancer Institute of New Jersey and and other U.S. health and academic institutions shows a diet high in calcium and low in lactose may reduce the risk of ovarian cancer in...
Know Your Risk for Ovarian Cancer -- and the Symptoms
Source: MedicineNet Cancer Causes Specialty [2016.09.12]
Title: Know Your Risk for Ovarian Cancer -- and the Symptoms
Category: Health News
Created: 9/9/2016 12:00:00 AM
Last Editorial Review: 9/12/2016 12:00:00 AM
FDA Warns Ovarian Cancer Tests Not Reliable
Source: MedicineNet Clinical Trials Specialty [2016.09.12]
Title: FDA Warns Ovarian Cancer Tests Not Reliable
Category: Health News
Created: 9/9/2016 12:00:00 AM
Last Editorial Review: 9/12/2016 12:00:00 AM
Are Birth Control Pills Tied to Decline in Ovarian Cancer Deaths?
Source: MedicineNet Ovarian Cancer Specialty [2016.09.07]
Title: Are Birth Control Pills Tied to Decline in Ovarian Cancer Deaths?
Category: Health News
Created: 9/7/2016 12:00:00 AM
Last Editorial Review: 9/7/2016 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)
Trientine and Carboplatin in Advanced Malignancies [Completed]
The goal of this clinical research study is to find the highest tolerable dose of the
combination of trientine and carboplatin that can be given to patients with advanced cancer.
The safety of this drug combination will also be studied.
Pazopanib (VOTRIENT) Plus Paclitaxel (TAXOL), Pazopanib Plus Paclitaxel (TAXOL) Plus Carboplatin (PARAPLATIN), and Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB) [Completed]
Pazopanib will be given with TAXOL in one part, in another part pazopanib will be given with
TAXOL and PARAPLATIN, and in a third part pazopanib will be given with TAXOL and lapatinib
(patients separated in each part). Toxicity monitoring will enable us to find the largest
dose of pazopanib daily that can be safely given in combination with the chemotherapy agents
TAXOL and PARAPLATIN, and with lapatinib, as well as what side effects are likely to
manifest when these agents are given together and whether the combination of pazopanib with
chemotherapy, helps to treat different types of cancer. Another objective is to find out how
much pazopanib, TAXOL, PARAPLATIN and lapatinib are in the blood at specific times after the
agents are given. Collecting the blood samples requires that the patients remain in the
vicinity of the clinic overnight on 2 occasions.
Heated Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Peritoneal Cancer [Recruiting]
This phase I trial studies the side effects and best dose of heated carboplatin given into
the abdomen at the time of surgery in treating patients with stage II-IV ovarian, fallopian
tube, or peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, work in
different ways to stop the growth of tumor cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. Heating oxaliplatin and infusing it
directly into the area around the tumor during surgery may kill more tumor cells.
Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS) [Recruiting]
The primary objective of this study is to compare the safety of 100 mg carboplatin
administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal
carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15
intraductal infusion. Secondary objectives are to characterize the biologic and clinical
effects with respect to: pharmacokinetics, extent of disease on MRI and mammogram,
histopathological assessment of DCIS, and biomarker measurement of Ki-67, TUNEL and G-actin.
A Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies [Terminated]
This study is designed to investigate the possibility that use of two similar but distinct
drugs used together in treatment of advanced cancer might prove less toxic than either agent
used alone, because dosages can be reduced for each agent. This is a phase I study that is
designed to measure the frequency and levels of specific side effects when Carboplatin and
Pazopanib are used in combination in advanced cancer patients. The possibility that
anti-tumor activity will occur is also going to be investigated.
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: 2016-09-20
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