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Paraplatin (Carboplatin) - Summary

 

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U.S. Patent No. 4,657,927

Bristol-Myers Squibb Company
Princeton, New Jersey 08543 USA
Made in Italy

1157981A1
Revised December 2003

WARNING

PARAPLATIN (carboplatin lyophilized powder) for 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 PARAPLATIN 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
Formerly: PARAPLATIN® (carboplatin for injection)

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.

PARAPLATIN NEWS HIGHLIGHTS

Media Articles Related to Paraplatin (Carboplatin)

Relapsed Ovarian Cancer Responds to Pegylated Liposomal Doxorubicin-Carboplatin
Source: Medscape Pharmacotherapy Headlines [2004.06.10]

Researchers ID Ovarian Cancer Biomarker
Source: MedicineNet Ovarian Cancer Specialty [2008.09.24]

Drug Combo Fights Recurrent Ovarian Cancer Cell Growth
Source: MedicineNet Cervical Cancer Specialty [2008.09.19]

Ovarian Cancer
Source: MedicineNet Cancer Causes Specialty [2008.07.10]

Symptoms Warn of Ovarian Cancer
Source: MedicineNet Inflammatory Bowel Disease: Intestinal Problems Specialty [2008.06.24]

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Published Studies Related to Paraplatin (Carboplatin)

A pharmacodynamic model for the time course of tumor shrinkage by gemcitabine + carboplatin in non-small cell lung cancer patients. [2008.07.01]

A phase Ib trial of docetaxel, carboplatin and erlotinib in ovarian, fallopian tube and primary peritoneal cancers. [2008.06.03]

Phase III study of valspodar (PSC 833) combined with paclitaxel and carboplatin compared with paclitaxel and carboplatin alone in patients with stage IV or suboptimally debulked stage III epithelial ovarian cancer or primary peritoneal cancer. [2008.06.01]

Phase III trial comparing paclitaxel poliglumex (CT-2103, PPX) in combination with carboplatin versus standard paclitaxel and carboplatin in the treatment of PS 2 patients with chemotherapy-naive advanced non-small cell lung cancer. [2008.06]

Carboplatin dosing in obese women with ovarian cancer: a Gynecologic Oncology Group study. [2008.06]

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Clinical Trials Related to Paraplatin (Carboplatin)

A Trial of Carboplatin and Gemcitabine Versus Gemcitabine Alone in Patients With Non-Small-Cell Lung Cancer [Completed]

Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Patients With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy [Recruiting]

Study Comparing Weekly Taxol and Carboplatin vs Standard Taxol and Carboplatin Regimen for Stage IIIB or IV Non-Small-Cell Lung Cancer [Completed]

Alternating Cycles of Carboplatin/Gemcitabine and Carboplatin/Taxol for Advanced Stage NSCLC [Recruiting]

Induction Chemotherapy Using Paclitaxel, Carboplatin, CPT-11 With Pegfilgrastim Followed by Radiotherapy and Paclitaxel/Carboplatin/ZD1839 in Locally Advanced Unresectable Stage IIIA/B Non-Small Cell Carcinoma of the Lung [Completed]

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Page last updated: 2008-09-24

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