Indications and Usage for Taxol. 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.
What is taxol used to treat?
Taxol is classified as a "plant alkaloid," a "taxane" and an "antimicrotubule agent." (For more detail, see "How Taxol Works" section below). Taxol is used for the treatment of breast, ovarian, lung, bladder, prostate, melanoma, esophageal, as well as other types of solid tumor cancers.
When was Taxol approved by the FDA?
Subsequent clinical trials found that the drug was effective against this disease, and, in 1994, the FDA approved Taxol for use against breast cancer. 4 Clinical trials to test Taxol against other types of cancer and in combination with other therapies are currently in progress. To date, Taxol is the best-selling cancer drug ever manufactured.
What happened to Taxol ®?
Suddenly, Taxol ® was “hot,” with some seeing it as a potential “miracle drug.” Then came a disastrous discovery: Taxol ® is virtually insoluble in water. No matter how good Taxol ® was shown to be, if it could not be added to a medium so that it could be administered intravenously, it was worthless.
Is there a generic version of Taxol?
The Taxol brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.
Which disease is treated by Taxol?
Taxol is used for the treatment of breast, ovarian, lung, bladder, prostate, melanoma, esophageal, as well as other types of solid tumor cancers. It has also been used in Kaposi's sarcoma.
What is the application of Taxol?
Taxol is a cancer medication that interferes with the growth and spread of cancer cells in the body. Taxol is used to treat breast cancer, ovarian cancer, and lung cancer. It is also used to treat AIDS-related Kaposi's sarcoma.
What does Taxol prevent?
Taxol stops the uncontrolled cell divisions of cancer by forming extremely stable and nonfunctional microtubules. The microtubules are the means of chromosome motion during mitosis (cell division). Mitosis is halted when the stable, nonfunctional microtubules fail to form a normal mitotic apparatus.
What type of breast cancer is Taxol used for?
When Taxol Is Used. The chemotherapy class of taxanes include the drugs Taxotere (docetaxel) and paclitaxel. Taxol is a versatile drug used to treat breast cancer. It can be used in both early-stage breast cancer and metastatic breast cancer (cancer that has spread to other organs).
When was Taxol approved?
Taxol, which is a chemical extracted from the bark, was selected for commercial development in 1977 and was first tested in patients in 1984. It was approved for use by the US Food and Drug administration in 1992 and by 2000 had annual sales of A$2.1 billion per year.
How many treatments does Taxol have?
Taxol, Taxotere, and Abraxane (chemical name: albumin-bound or nab-paclitaxel) are all taxanes. In the AC followed by T regimen, a taxane is usually given as 4 treatments over 12 weeks -- 1 treatment every 3 weeks.
Why does Taxol treatment stabilize microtubules?
The antitumor drug Taxol stabilizes microtubules and reduces their dynamicity, promoting mitotic arrest and cell death. Upon assembly of the α/β-tubulin heterodimer, GTP bound to β-tubulin is hydrolyzed to GDP reaching a steady-state equilibrium between free tubulin dimers and microtubules.
Does Taxol stop anaphase?
The concentration of taxol that suppressed dynamics in interphase cells was also found to inhibit cell proliferation and block mitosis by preventing progression from metaphase to anaphase.
How does Taxol stop cell division quizlet?
Taxol interferes with that process by inhibiting the shortening of the microtubules attached to the sister chromatids, so the chromatids do not separate and they do not move to the ends of the cells. Ultimately the cell is unable to divide.
What structure does Taxol target?
For more than 25 years, researchers have known that Taxol targets microtubules and prevents cells from dividing, which then triggers apoptosis, a cellular mechanism also referred to as programmed cell death.
What are other names for Taxol?
Paclitaxel is used to treat various types of cancer. It is a cancer chemotherapy drug that works by slowing or stopping cancer cell growth. Paclitaxel is available under the following different brand names: Taxol.
What is the mechanism of action of Taxol?
Mechanism of action Paclitaxel-treated cells have defects in mitotic spindle assembly, chromosome segregation, and cell division. Unlike other tubulin-targeting drugs, such as colchicine, that inhibit microtubule assembly, paclitaxel stabilizes the microtubule polymer and protects it from disassembly.
What Happens If I Overdose?
Overdose symptoms may include numbness or tingling, fever, chills, mouth sores, unusual bleeding or weakness, or any signs of infection.
What Other Drugs Will Affect Taxol?
There are many other medicines that can interact with Taxol. Tell your doctor about all the prescription and over-the-counter medications you use....
What Does My Medication Look like?
1. Taxol is available with a prescription under the brand names Onxol and Taxol. Other brand or generic formulations may also be available. Ask you...
How long does it take for Taxol to work?
After failure of initial chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, Taxol at a dose of 175 mg/m 2 administered intravenously over 3 hours every 3 weeks has been shown to be effective.
What is the binding concentration of Paclitaxel?
In vitro studies of binding to human serum proteins, using paclitaxel concentrations ranging from 0.1 to 50 µg/mL, indicate that between 89 to 98% of drug is bound; the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine did not affect protein binding of paclitaxel.
Can taxol be rechallenged?
(See DOSAGE AND ADMINISTRATION .) Patients who experience severe hypersensitivity reactions to Taxol should not be rechallenged with the drug.
Can you give taxol to other people?
Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Taxol for a condition for which it was not prescribed. Do not give Taxol to other people, even if they have the same symptoms that you have. It may harm them.
Is there an antidote for Taxol?
There is no known antidote for Taxol (paclitaxel) overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, peripheral neurotoxicity, and mucositis. Overdoses in pediatric patients may be associated with acute ethanol toxicity (see PRECAUTIONS: Pediatric Use ).
Does Paclitaxel inhibit microtubules?
Paclitaxel is a novel antimicrotubule agent that promotes the assembly of microtubules from tubulin di mers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. In addition, paclitaxel induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Can taxol harm pregnant women?
Taxol can cause fetal harm when administered to a pregnant woman. Administration of paclitaxel during the period of organogenesis to rabbits at doses of 3.0 mg/kg/day (about 0.2 the daily maximum recommended human dose on a mg/m 2 basis) caused embryo- and fetotoxicity, as indicated by intrauterine mortality, increased resorptions, and increased fetal deaths. Maternal toxicity was also observed at this dose. No teratogenic effects were observed at 1.0 mg/kg/day (about 1/15 the daily maximum recommended human dose on a mg/m 2 basis); teratogenic potential could not be assessed at higher doses due to extensive fetal mortality.
How is taxol given?
How Taxol Is Given: Taxol is given as an injection or infusion into the vein (intravenous, IV). Taxol is an irritant. An irritant is a chemical that can cause inflammation of the vein through which it is given. If the medication escapes from the vein it can cause tissue damage.
What is taxol chemo?
What is Taxol? Taxol is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug . Taxol is classified as a "plant alkaloid," a "taxane" and an "antimicrotubule agent." (For more detail, see "How Taxol Works" section below).
What is the name of the plant that makes taxol?
Plant alkaloids are made from plants. The vinca alkaloids are made from the periwinkle plant (catharanthus rosea). The taxanes are made from the bark of the Pacific Yew tree (taxus).
How long does it take for a numbness to go away after taking Taxol?
Arthralgias and myalgias, pain in the joints and muscles. Usually temporary occurring 2 to 3 days after Taxol, and resolve within a few days. Peripheral neuropathy (numbness and tingling of the hands and feet) Nausea and vomiting (usually mild) Diarrhea. Mouth sores.
What to do if you have pain while taking Taxol?
If you experience pain or notice redness or swelling at the IV site while you are receiving Taxol, alert your health care professional immediately. Because severe allergic reactions have occurred in some people taking Taxol, you will be asked to take medications to help prevent a reaction.
Does taxol have side effects?
Taxol side effects are almost always reversible and will go away after treatment is complete. There are many options to help minimize or prevent Taxol side effects. There is no relationship between the presence or severity of Taxol side effects and the effectiveness of the medication. The Taxol side effects and their severity vary depending on ...
Can you take aspirin before taking Taxol?
Before starting Taxol treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, or products containing aspirin unless your doctor specifically permits this.
When was taxol approved?
4. 1992–present In December 1992, the FDA approved Taxol for the treatment for ovarian cancer.
Why was Taxol so slow to develop?
Because of difficulties harvesting Taxol and because of the complexities involved in synthesizing the compound, development toward the clinic was slow. The drug, however, showed effectiveness against mammary tumors and ovarian cancer, pushing researchers to find a means of isolating large quantities for clinical use.
What is the name of the tree that is used for ovarian cancer?
Taxol® (NSC 125973) Paclitaxel, the most well-known natural-source cancer drug in the United States, is derived from the bark of the Pacific yew tree ( Taxus brevifolia) and is used in the treatment of breast, lung, and ovarian cancer, as well as Kaposi's sarcoma.
When was Taxol used in mouse models?
1977 It was not until 1977, when NCI was able to confirm antitumor activity in the mouse melanoma B16 model, that paclitaxel, also known by its trade name, Taxol, was selected as a candidate for clinical development. Activity was also observed in animal models against MX-1 mammary, LX-1 lung, and CX-1 colon tumors.
Is taxol good for breast cancer?
Researchers also tested the effectiveness of Taxol as a treatment for advanced breast cancer. Subsequent clinical trials found that the drug was effective against this disease, and, in 1994, the FDA approved Taxol for use against breast cancer. 4. Clinical trials to test Taxol against other types of cancer and in combination with other therapies ...
Who was the woman who asked for taxol?
In August 1978 Monroe Wall received a letter from John Douros, who had replaced Jonathan Hartwell at the CCNSC, that read: “Dear Monroe: Can you help this poor girl?” Attached was a letter from Susan Horwitz asking for some radiolabeled Taxol ® to conduct experiments on its mechanism of action. Like many researchers, Horwitz, a molecular pharmacologist in the Albert Einstein College of Medicine at New York’s Yeshiva University, had been hearing reports about Taxol ®. She had managed to obtain a few milligrams of the substance, which she used to kill cancer cells growing in a culture. Determined to find out how it worked, Horwitz pressured NCI to get her more Taxol ®.
Where is Camptothecin and Taxol located?
The American Chemical Society designated the discovery of camptothecin and Taxol ® as a National Historic Chemical Landmark at the Research Triangle Institute in Research Triangle Park, North Carolina, on April 23, 2003. The plaque commemorating the discovery reads:
How much did the National Cancer Institute spend in 1937?
As a consequence, the budget of the National Cancer Institute (NCI) grew from $0.5 million in 1937, its first year, to $1.75 million in 1946 and $14 million in 1951 (ten years later the budget reached $110 million). And there was more money from the National Institutes of Health and from private sources for research grants.
Does camptothecin prevent cancer cell replication?
This prevents cancer cell DNA replication and results in the death of the cancer cell. This unique mode of action rekindled interest in developing analogs of camptothecin that were both water soluble and retained anticancer activity.
Who wrote the article "The joint effort of chemists and botanists proved to be a good
In 1966 Monroe Wall wrote of his work at the Eastern Regional Research Laboratory: “The joint effort of chemists and botanists proved to be a good model for future programs. Indeed, it firmly established the fact that the close cooperation between chemists and botanists was required for a successful natural products program.” 1
Is camptothecin soluble in water?
But camptothecin is not soluble in water (which makes delivery of a potential drug difficult) so the trials were conducted with a water-soluble sodium salt that could be formulated for intravenous delivery. In the trials, some patients with gastrointestinal tumors responded to treatment for a short time.
What is the new treatment for juvenile arthritis?
In 2020, CDER approved two new therapies for the treatment of polyarticular juvenile idiopathic arthritis, a type of juvenile arthritis (arthritis in children) that causes inflammation in five or more joints within the first six months of the disease. CDER also approved a new therapy for pediatric patients with ulcerative colitis, a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops open sores, or ulcers. Additionally, CDER approved a new therapy to treat patients with chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype (trait)—the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time.
What is the CDER approved therapy for?
CDER approved a new therapy to help raise excessively low levels of phosphate in the blood (induced by a specific type of tumor) in certain patients with osteomalacia (softening of the bones).
What is Farxiga used for?
Farxiga (dapagliflozin), tablets, originally approved by CDER in 2014 as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults with type 2 diabetes.
Is quinidine FDA approved?
Prior to this approval, there had been no FDA-approved drug for treatment of severe malaria in the U.S. since the marketing of quinidine was discontinued by the manufacturer in March 2019. Approximately 2,000 cases of malaria are diagnosed in the U.S. each year, with 300 of those infected having severe disease.
Is there a new FDA approved treatment for heavy menstrual bleeding?
In other advances of 2020, CDER approved a new combination of already FDA-approved drugs for the management of heavy menstrual bleeding associated with fibroids (a kind of tumor typically non-cancerous) in premenopausal women. Additionally, 2020 saw the first FDA-approved therapy for certain pediatric patients with neurogenic detrusor overactivity, a bladder dysfunction frequently observed in patients with multiple sclerosis and spinal cord injury.
Taxol Description
Taxol - Clinical Pharmacology
- Paclitaxel is a novel antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. In addition, paclitaxel induces abnormal array…
Clinical Studies
- Ovarian Carcinoma
The safety and efficacy of Taxol followed by cisplatin in patients with advanced ovarian cancer and no prior chemotherapy were evaluated in 2, Phase 3 multicenter, randomized, controlled trials. In an Intergroup study led by the European Organization for Research and Treatment of Cancer i… - Breast Carcinoma
A Phase 3 Intergroup study (Cancer and Leukemia Group B [CALGB], Eastern Cooperative Oncology Group [ECOG], North Central Cancer Treatment Group [NCCTG], and Southwest Oncology Group [SWOG]) randomized 3170 patients with node-positive breast carcinoma to adju…
Indications and Usage For Taxol
- 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 ...
Contraindications
- Taxol is contraindicated in patients who have a history of hypersensitivity reactions to Taxol or other drugs formulated in Cremophor®EL (polyoxyethylated castor oil). Taxol should not be used in patients with solid tumors who have baseline neutrophil counts of <1500 cells/mm3 or in patients with AIDS-related Kaposi’s sarcoma with baseline neutrophil counts of <1000 cells/mm3.
Warnings
- 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. (S…
Precautions
- Contact of the undiluted concentrate with plasticized polyvinyl chloride (PVC) equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted Taxol solutions should preferably be stored in bottles (glass, polyp…
Adverse Reactions
- Pooled Analysis of Adverse Event Experiences from Single-Agent Studies
Data in the following table are based on the experience of 812 patients (493 with ovarian carcinoma and 319 with breast carcinoma) enrolled in 10 studies who received single-agent Taxol. Two hundred and seventy-five patients were treated in 8, Phase 2 studies with Taxol dose… - Disease-Specific Adverse Event Experiences
For the 1084 patients who were evaluable for safety in the Phase 3 first-line ovary combination therapy studies, TABLE 11shows the incidence of important adverse events. For both studies, the analysis of safety was based on all courses of therapy (6 courses for the GOG-111 study and up …
Overdosage
- There is no known antidote for Taxol (paclitaxel) overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, peripheral neurotoxicity, and mucositis. Overdoses in pediatric patients may be associated with acute ethanol toxicity (see PRECAUTIONS: Pediatric Use).
Taxol Dosage and Administration
- Note: Contact of the undiluted concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted Taxol solutions should be stored in bottles (glass, polypropylene) or plastic bags (p…
Uses
Discovery
Chemistry
Mechanism
Synthesis
Toxicity
Research
Medical uses
- 1992present In December 1992, the FDA approved Taxol for the treatment for ovarian cancer. Researchers also tested the effectiveness of Taxol as a treatment for advanced breast cancer. Subsequent clinical trials found that the drug was effective against this disease, and, in 1994, the FDA approved Taxol for use against breast cancer.4
Society and culture