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)
Leukemia Drug May Help Some Ovarian Cancer Patients (HealthDay)
Source: Y! Health News Search RSS Feed [2009.11.12]
HealthDay - THURSDAY, Nov. 12 (HealthDay News) -- A drug for people with a form of
leukemia holds promise as a possible treatment for ovarian cancer, new
research suggests.
Leukemia Drug May Help Some Ovarian Cancer Patients
Source: MedicineNet Leukemia Specialty [2009.11.12]
Title: Leukemia Drug May Help Some Ovarian Cancer Patients
Category: Health News
Created: 11/12/2009 8:10:00 AM
Last Editorial Review: 11/12/2009
FDA Approved Leukemia Drug Shows Promising Activity In Ovarian Cancer Cells
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.11]
The drug Sprycel, approved for use by the U.S. Food and Drug Administration in patients with chronic myeloid leukemia, significantly inhibited the growth and invasiveness of ovarian cancer cells and also promoted their death, a study by researchers with UCLA's Jonsson Comprehensive Cancer Center found.
New Chemo Regimen May Benefit Ovarian Cancer Patients
Source: MedicineNet Ovarian Cancer Specialty [2009.09.21]
Title: New Chemo Regimen May Benefit Ovarian Cancer Patients
Category: Health News
Created: 9/20/2009 8:10:00 AM
Last Editorial Review: 9/21/2009
FDA OKs New Ovarian Cancer Blood Test
Source: MedicineNet Ovarian Cancer Specialty [2009.09.14]
Title: FDA OKs New Ovarian Cancer Blood Test
Category: Health News
Created: 9/14/2009 11:12:00 AM
Last Editorial Review: 9/14/2009 11:12:02 AM
Published Studies Related to Paraplatin (Carboplatin)
Randomized Double-Blind Placebo-Controlled Trial of Thalidomide in Combination With Gemcitabine and Carboplatin in Advanced Non-Small-Cell Lung Cancer. [2009.10.13]
PURPOSE: Cancers rely on angiogenesis for their growth and dissemination. We hypothesized that thalidomide, an oral antiangiogenic agent, when combined with chemotherapy, and as maintenance treatment, would improve survival in patients with advanced non-small-cell lung cancer (NSCLC)... CONCLUSION: In this large trial of patients with NSCLC, thalidomide in combination with chemotherapy did not improve survival overall, but increased the risk of thrombotic events. Unexpectedly, survival was significantly worse in patients with nonsquamous histology.
A Phase III Trial of Paclitaxel plus Carboplatin Versus Paclitaxel plus Cisplatin in Stage IVB, Persistent or Recurrent Cervical Cancer: Gynecologic Cancer Study Group/Japan Clinical Oncology Group Study (JCOG0505). [2009.10.12]
A randomized controlled trial has been started in Japan to compare the utility of palliative chemotherapy containing paclitaxel and carboplatin (TC) with paclitaxel and cisplatin (TP) as a standard treatment for patients with the newly diagnosed Stage IVB, persistent or recurrent cervical cancer who are not amenable to curative treatment with local therapy...
Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. [2009.09.03]
BACKGROUND: Previous, uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer... CONCLUSIONS: Gefitinib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia. The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib. (ClinicalTrials.gov number, NCT00322452.) 2009 Massachusetts Medical Society
Neoadjuvant chemotherapy with carboplatin and docetaxel in advanced ovarian cancer--a prospective multicenter phase II trial (PRIMOVAR). [2009.09]
Early response criteria and surgical outcome were evaluated in patients with advanced epithelial ovarian cancer treated with neoadjuvant chemotherapy. Patients with FIGO stage IIIC or IV ovarian cancer and an ascites volume of >or=500 ml were randomly assigned to receive preoperatively 3 (A1) or 2 (A2) of 6 cycles of carboplatin and docetaxel intravenously...
Efficacy of carboplatin-taxane combinations in the management of castration-resistant prostate cancer: a pooled analysis of seven prospective clinical trials. [2009.07.24]
BACKGROUND: Docetaxel is associated with prolonged survival in castration-resistant prostate cancer (CRPC). Platinum compounds have modest but distinct single-agent activity. Carboplatin may have greatest potential for benefit when combined with taxanes. We investigated whether there is a subset of patients with CRPC for whom the efficacy of combination taxane-estramustine-carboplatin (TEC) chemotherapy may be greatest... CONCLUSIONS: TEC chemotherapy has significant clinical activity in CRPC. A randomized, controlled trial evaluating the addition of carboplatin to taxane-based chemotherapy is needed to elucidate the value of carboplatin in CRPC.
Clinical Trials Related to Paraplatin (Carboplatin)
A Trial of Carboplatin and Gemcitabine Versus Gemcitabine Alone in Patients With Non-Small-Cell Lung Cancer [Completed]
To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin
versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.
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]
The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab
plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival
time without disease progression in the first-line treatment of patients with advanced stage
non-small cell lung cancer.
Study Comparing Weekly Taxol and Carboplatin vs Standard Taxol and Carboplatin Regimen for Stage IIIB or IV Non-Small-Cell Lung Cancer [Completed]
Taxol and carboplatin are commonly used drugs for the treatment of stage IIIB or IV non small
cell lung carcinoma.
This study compares treatment with Taxol/carboplatin given every 3 weeks to a schedule where
it is given weekly.
The purpose of the study is to determine the most effective and safe schedule for giving
these drugs in non small cell lung carcinoma.
Alternating Cycles of Carboplatin/Gemcitabine and Carboplatin/Taxol for Advanced Stage NSCLC [Recruiting]
To see the efficacy of using chemotherapies alternatively (carboplatin and gemcitabine alternating with carboplatin and taxol) for pts with stage IIIB (nonresectable and stage IV NSCLC.
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]
Patients enrolled on this study will have been diagnosed with non-small cell lung cancer
which cannot be removed by an operation. The standard treatment for this disease is a
combination of chemotherapy and radiation therapy; however, the best way to combine these
treatments is not known. This study will examine if the combination of chemotherapy and
radiotherapy has an increased effect on slowing tumor growth with the addition of a drug
called ZD1839.
In this study, chemotherapy will be given initially (induction therapy) to try to control the
spread of the cancer. Then radiation and chemotherapy will be given together. Receiving
chemotherapy at the same time as radiation treatments can enhance the effect of the
radiation. In this study, patients will receive a drug called ZD1839. In laboratory tests on
cancer cells, ZD1839 has shown an additive effect when used in combination with radiation.
ZD1839 has also been shown to slow or stop growth in tumors.
The purpose of this study is to determine the side effects and effectiveness of using ZD1839
when used with radiation in this treatment regimen (induction chemotherapy followed by
combination chemotherapy, ZD1839, and radiation therapy).
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