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Paraplatin (Carboplatin) - Summary

 
 



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.

 

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.


See all Paraplatin indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Paraplatin (Carboplatin)

Beta-Blockers: Evidence of Mortality Benefit in Ovarian Cancer (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.28]
(MedPage Today) -- Survival more than doubled in patients receiving agents like propranolol

Blood Pressure Drugs Linked to Longer Ovarian Cancer Survival
Source: MedicineNet Clinical Trials Specialty [2015.08.25]
Title: Blood Pressure Drugs Linked to Longer Ovarian Cancer Survival
Category: Health News
Created: 8/24/2015 12:00:00 AM
Last Editorial Review: 8/25/2015 12:00:00 AM

Beta-blocker Use Linked to Improved Ovarian Cancer Survival
Source: Medscape Hematology-Oncology Headlines [2015.08.24]
In a large, retrospective study of women with ovarian cancer, use of nonselective beta-blockers was associated with longer survival than nonuse.
Medscape Medical News

Multigene panel testing for hereditary breast/ovarian cancer risk assessment
Source: Breast Cancer News From Medical News Today [2015.08.19]
Multigene testing of women negative for BRCA1 and BRCA2 found some of them harbored other harmful genetic mutations, most commonly moderate-risk breast and ovarian cancer genes and Lynch syndrome...

Study of multi gene panel shows heredity risk of breast and ovarian cancer
Source: Breast Cancer News From Medical News Today [2015.08.17]
Invitae Corporation, a genetic information company, and its collaborators have announced the publication of new data describing the clinical actionability of multi-gene testing for hereditary...

more news >>

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

more studies >>

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.

more trials >>

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 >>


Page last updated: 2015-08-28

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