WARNING
TAXOL® (paclitaxel) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving TAXOL in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists. (See DOSAGE AND ADMINISTRATION.) Patients who experience severe hypersensitivity reactions to TAXOL should not be rechallenged with the drug.
TAXOL therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm3 and should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline neutrophil count is less than 1000 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving TAXOL.
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TAXOL SUMMARY
TAXOL (paclitaxel) Injection is a clear colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion.
TAXOL is indicated as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, TAXOL is indicated in combination with cisplatin.
TAXOL is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors. (See CLINICAL STUDIES: Breast Carcinoma.)
TAXOL is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
TAXOL, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.
TAXOL is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.
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NEWS HIGHLIGHTSMedia Articles Related to Taxol (Paclitaxel)
FDA Expands Agent's Orphan Drug Status
Source: MedPage Today Product Alert [2009.11.05]
WASHINGTON (MedPage Today) -- The FDA has extended the orphan drug status of the breast cancer agent protein-bound paclitaxel (Abraxane) for use in stage IIB-IV melanoma treatment.
Published Studies Related to Taxol (Paclitaxel)
A Phase II, Randomized, Controlled, Double-Blinded Trial of Weekly Elesclomol Plus Paclitaxel Versus Paclitaxel Alone for Stage IV Metastatic Melanoma. [2009.10.13]
PURPOSE: Elesclomol is a novel, small-molecule, oxidative stress inducer believed to exert selective cytotoxicity by increasing intracellular concentrations of reactive oxygen species, which results in cell death via mitochondrial apoptosis. We evaluated whether the addition of elesclomol to weekly paclitaxel could improve efficacy in patients with stage IV metastatic melanoma... CONCLUSION: E + P resulted in a statistically significant doubling of median PFS, with an acceptable toxicity profile and encouraging OS. A multinational, phase III trial (SYMMETRY) of E + P compared with paclitaxel alone in metastatic melanoma has closed.
Final 5-year results of the TAXUS II trial: a randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for de novo coronary artery lesions. [2009.10.13]
CONCLUSIONS: TAXUS II is the first large TAXUS trial to have reached 5-year follow-up. Both the SR and MR stents lowered the rates of target-vessel and target-lesion revascularization, which indicates their sustained efficacy. Furthermore, the low overall rates of all death, myocardial infarction, and stent thrombosis support the long-term safety of the TAXUS stent system.
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...
SPIRIT IV trial design: a large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease. [2009.10]
BACKGROUND: In the 300-patient SPIRIT II and 1002-patient SPIRIT III randomized trials, the everolimus-eluting stent (EES) compared to the paclitaxel-eluting stent (PES) resulted in reduced angiographic late loss (a primary end point in both trials), noninferior rates of 9-month target vessel failure (a primary end point in SPIRIT III), and reduced rates of target lesion revascularization and major adverse cardiac events (secondary end points)...
Long-Term outcome of drug-eluting stents compared with bare metal stents in ST-segment elevation myocardial infarction: results of the paclitaxel- or sirolimus-eluting stent versus bare metal stent in Primary Angioplasty (PASEO) Randomized Trial. [2009.09.15]
CONCLUSIONS: This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are associated with significant benefits in terms of target lesion revascularization at the long-term follow-up compared with BMS with no excess risk of thrombotic complications. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered among STEMI patients undergoing primary angioplasty.
Clinical Trials Related to Taxol (Paclitaxel)
Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced Cancer [Active, not recruiting]
In this study, Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) is being compared to
Taxol® to examine whether the paclitaxel in these 2 formulations undergoes similar processing
by the body. Safety and tolerability of LEP-ETU and Taxol will also be assessed. In this
study, each patient will receive one intravenous infusion of LEP-ETU or Taxol, followed 3
weeks later by an infusion of the other drug, at the same dose and infusion duration.
Multiple blood samples will be taken for analysis before, during, and after both drug
infusions. Upon completing these 2 Cycles of treatment, eligible patients may enroll in an
extension study (LEP-ETU-102B) to continue treatment with LEP-ETU.
LEP-ETU is a liposomal formulation of paclitaxel, a widely used anti-cancer drug. This
LEP-ETU formulation of paclitaxel is being developed to potentially reduce toxicities
associated with Taxol, by eliminating the drug formulation component polyoxyethylated castor
oil (Cremophor® EL). In LEP-ETU, paclitaxel is associated with liposomes, which are
microscopic membrane-like structures created from lipids (fats). Thus, the LEP-ETU
formulation could potentially have reduced toxicity, while maintaining or enhancing
efficacy.
Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways
to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with
ABI-007 may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with
ABI-007 in treating patients who have locally advanced or metastatic solid tumors.
Study of Dose-Dense Adriamycin Plus Cytoxan (AC) Followed by Either Abraxane or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer [Active, not recruiting]
The primary objective of this study is to compare the safety of dose-dense Abraxane 260
mg/m^2 or Taxol 175 mg/m^2 given every 2 weeks following dose-dense AC chemotherapy.
Bevacizumab will be administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then
at 15 mg/kg every 3 weeks following chemotherapy.
ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer [Completed]
The anticancer agent paclitaxel (marketed as Taxol) has shown remarkable activity against
metastatic breast cancer. However, the Taxol formulation requires prolonged administration
times, and there are safety problems that have been attributed to the solvent rather than the
active ingredient, paclitaxel. This is a new formulation of paclitaxel that has been found
to have fewer safety problems than Taxol, and may be administered safely at higher doses.
This study will investigate the safety and efficacy of this new formulation of paclitaxel
given intravenously once a week for three weeks, followed by a rest week. This cycle will be
repeated until safety problems or treatment failure require that the patient stop therapy.
Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer [Active, not recruiting]
The purpose of this study is to determine the effectiveness and safety of administering
Herceptin in combination with Taxol (paclitaxel) in the treatment of women with
HER2-positive, early stage breast cancer prior to surgery.
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Page last updated: 2009-11-05
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