> Do any of the medical experts here know anything about Xyotax? I've heard
> that it is like Taxol, but with a lot less side effects. I don't think it is
> actually on the market yet, though.
You can find clinical trials by searching CT-2103 http://www.clinicaltrials.gov/
various phases/treatment combos/
No longer recruiting unfortunately.
There's a phase III for NSCLC. I haven't looked at each of the others.
http://patient.cancerconsultants.com/rectal_cancer_news.aspx?id=17471
Paclitaxel (Taxol®) is the most commonly used chemotherapy agent in the world.
However, some side effects caused by paclitaxel may decrease a patient?s quality
of life and cause a reduction in the dose of therapy. Researchers recently
created a new form of paclitaxel, which involves the active form of the drug
bound to molecules called polyglutamate polymers. These molecules tends to allow
for the delivery of higher levels of the active drug to cancer cells, while
sparing healthy cells from side effects
(some clinical trials are mentioned on that web page)
<http://www.asco.org/ac/1,1003,_12-002489-00_18-0023-00_19-00104326-00_29-00A,00.
asp?AbstractID=104326&cat=&parent=Breast+Cancer&returnpid=2325>
Meeting: 2003 ASCO Annual Meeting
Printer Friendly
Bookmark
Category: Breast Cancer
SubCategory: Metastatic Breast Cancer
A phase 2 study of CT-2103, a poly(L-glutamic acid)-paclitaxel conjugate
administered every 3 weeks in patients with advanced breast cancer
Abstract No: 169
Citation: Proc Am Soc Clin Oncol 22: page 42, 2003 (abstr 169)
Author(s): L. Robson, M. Verrill, M. J. Lind, P. Simmons, T. Perren, C. Coombes,
H. Earl, H. Calvert, M. Campbell, M. G. Bolton; Cancer Research UK,
Northumberland, UK; Newcastle General Hospital, Newcastle upon Tyne, UK; The
Princess Royal Hospital, Hull, UK; Royal South Hants Hospital, Southampton, UK;
St James University Hospital, Leeds, UK; Charing Cross Hospital, London, UK;
Addenbrookes Hospital, Cambridge, UK; Cancer Research UK, London, UK; Cell
Therapeutics, Inc., Seattle, WA
Abstract: CT-2103 (XYOTAX) is a water-soluble poly (L-glutamic acid)-paclitaxel
conjugate, designed to have preferential tissue distribution to tumours and
enhanced activity in in-vivo xenograft models.
In this six centre, UK, phase 2 study (opened to recruitment June 2002), CT-2103
is administered at 235mg/m2 (conjugated paclitaxel) as a ten minute intravenous
infusion every three weeks to patients with advanced breast cancer. A majority
of patients had received anthracycline therapy. To date 17 patients have been
entered (11 taxane-naïve, 6 taxane-resistant).
Drug-related Grade 3 toxicities were nausea and vomiting (7 patients) and 4
patients had peripheral neuropathy which lead to discontinuation of treatment.
Grade 4 neutropaenia has been observed in 4 patients with one associated sepsis.
This patient had a compromised liver function and elevated bilirubin due to
extensive metastases and died. A subsequent protocol amendment excludes patients
with evidence of hepatic obstruction. No hypersensitivity reactions (HSR) have
been observed and patients have not required pre-medications to prevent HSR. No
patients have experienced alopecia or any other clinically significant adverse
event. Most patients are currently too early to assess for responses but two
unconfirmed partial responses have been observed, one taxane-naïve and one
taxane-resistant patient. The early activity in patients with advanced
metastatic breast cancer (including a taxane-resistant patient) is encouraging
and if sustained would warrant further development for this indication.
Looks like this is from last year.
They don't say which study the results are from. So perhaps the Phase III is
still outstanding on results. - You could ?contact the places mentioned in the
study to find out if the trials finished?
http://www.insidebayarea.com/portlet/article/html/fragments/print_article.jsp?ar
ticle=2600170
Bloomberg News
Inside Bay Area
Cell Therapeutics Inc. said its experimental lung-cancer treatment Xyotax failed
to boost survival more than an older chemotherapy drug in a study. Its shares
slid 48 percent, the most in more than 51/2 years.
Patients with the most common type of lung cancer who received Xyotax had the
same chance of surviving as those getting Bristol-Myers Squibb Co.'s Taxol,
Seattle-based Cell Therapeutics said in a statement Monday. Xyotax did reduce
adverse side effects such as hair loss, pain and heart symptoms.
The findings may delay Cell Therapeutics from seeking U.S. approval of Xyotax
until more studies are completed later this year, analysts said. The company,
which has one leukemia drug on the market, won priority review status for Xyotax
in 2003 from the U.S. Food and Drug Administration based on expectations it
might improve cancer treatment.
"They would have used these results, if positive, to complete the application
and they obviously can't do that now," Buddy Lyons, an analyst with Stanford
Group in Memphis, Tenn., who rates Cell Therapeutics shares "buy," said in a
telephone interview. The change may postpone potential approval until the middle
of 2006, he said.
<http://www.anti-cancerdrugs.com/pt/re/anticd/abstract.00001813-200503000-00003.h
tm;jsessionid=C1639EeN9xYI1ltsGLVHuV1H1zvS34dA9i1IfewsK0xXtUQt9HWg!1578349637!-9
49856031!9001!-1>
Paclitaxel poliglumex (XYOTAX; CT-2103): an intracellularly targeted taxane.
Anti-Cancer Drugs. 16(3):243-254, March 2005.
Singer, Jack W. a; Shaffer, Scott a; Baker, Brian a; Bernareggi, Alberto b;
Stromatt, Scott a; Nienstedt, Drew a; Besman, Marc a
Abstract:
Paclitaxel poliglumex (CT-2103; XYOTAX) is an innovative macromolecular taxane
designed to increase the therapeutic index of paclitaxel. This large
macromolecule conjugate of paclitaxel and poly-L-glutamic acid accumulates in
tumor tissues by taking advantage of the enhanced permeability of tumor
vasculature and lack of lymphatic drainage. Paclitaxel poliglumex prolongs
exposure to active drug and minimizes systemic exposure. Preclinical studies in
animal tumor models demonstrate enhanced safety and efficacy relative to
paclitaxel when administered as a single agent or in conjunction with radiation.
Clinical pilot studies with paclitaxel poliglumex showed improved outcomes
compared to standard taxanes and allowed a more convenient administration
schedule. Human pharmacokinetic data are consistent with prolonged tumor
exposure to active drug and a limited systemic exposure. Based on these results,
three ongoing randomized phase III trials were initiated to test the efficacy of
paclitaxel poliglumex in patients with advanced non-small cell lung carcinoma.
(C) 2005
http://theoncologist.alphamedpress.org/cgi/content/abstract/9/4/398
The Oncologist, Vol. 9, No. 4, 398405, July 2004
© 2004 AlphaMed Press
Dilemmas in Management: The Controversial Role of Chemotherapy in PS 2 Advanced
NSCLC and the Potential Role of CT-2103 (XyotaxTM)
Corey J. Langer
Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA
Correspondence: Corey J. Langer, M.D., Medical Director, Thoracic Oncology, Fox
Chase Cancer Center, 7701 Burholme Avenue, Philadelphia, Pennsylvania 19111.
Telephone: 215-728-2985; Fax: 215-728-3639; e-mail: CJ_Langer@fccc.edu
Platinum-based chemotherapy improves long-term survival in patients with
advanced non-small cell lung cancer (NSCLC). Meta-analyses have demonstrated an
improvement in median and 1-year survival times as well as quality of life.
However, these benefits are largely confined to patients with a good performance
status (PS), one of the most critical determinants influencing outcome. Several
clinical trials that initially included PS 2 patients ultimately discontinued
their enrollment due to a high propensity of adverse reactions to treatment. The
advent of more active, less toxic agents has revitalized investigator interest
in treating PS 2 patients. CT-2103 is a novel paclitaxel conjugate undergoing
investigation in the treatment of advanced NSCLC. The median survival for PS 2
patients treated with single-agent CT-2103 in one small trial proved similar to
that reported for paclitaxel/carboplatin in NSCLC patients and was associated
with an improved safety profile compared with conventional taxanes. Phase III
studies comparing CT-2103 as a single agent and in combination with carboplatin
to current standards of care are in progress. Unlike a well-defined population
with good PS, the therapeutic index in PS 2 patients is narrower and not as
clearly defined. These and other efforts will determine the optimal mode of
therapy in PS 2 individuals with NSCLC.
I don't know if this helps you or not.
Post again, if other questions.
J