XELODA Warfarin Interaction: Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. A clinically important XELODA-Warfarin drug interaction was demonstrated in a clinical pharmacology trial (see
PRECAUTIONS). Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon. Postmarketing reports have shown clinically significant increases in prothrombin time (PT) and INR in patients who were stabilized on anticoagulants at the time XELODA was introduced. These events occurred within several days and up to several months after initiating XELODA therapy and, in a few cases, within 1 month after stopping XELODA. These events occurred in patients with and without liver metastases. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.
XELODA (capecitabine) is a fluoropyrimidine carbamate with antineoplastic activity. It is an orally administered systemic prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR) which is converted to 5-fluorouracil.
- XELODA is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. XELODA was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Although neither XELODA nor combination chemotherapy prolongs overall survival (OS), combination chemotherapy has been demonstrated to improve disease-free survival compared to 5-FU/LV. Physicians should consider these results when prescribing single-agent XELODA in the adjuvant treatment of Dukes' C colon cancer.
- XELODA is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with XELODA monotherapy. Use of XELODA instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.
- XELODA in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
- XELODA monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated, eg, patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.
Published Studies Related to Xeloda (Capecitabine)
Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable
locally advanced or metastatic gastric or gastroesophageal junction cancer:
randomized, double-blind, phase III study (AVATAR study). 
cancer... CONCLUSIONS: Addition of bevacizumab to capecitabine-cisplatin in Chinese
Simvastatin plus capecitabine-cisplatin versus placebo plus
capecitabine-cisplatin in patients with previously untreated advanced gastric
cancer: a double-blind randomised phase 3 study. 
patients with previously untreated advanced gastric cancer (AGC)... CONCLUSIONS: Addition of 40 mg simvastatin to XP does not increase PFS in our
Sorafenib or placebo with either gemcitabine or capecitabine in patients with
HER-2-negative advanced breast cancer that progressed during or after
CONCLUSION: The addition of sorafenib to gemcitabine/capecitabine provided a
Randomized Placebo-Controlled Phase II Trial of Perifosine Plus Capecitabine As Second- or Third-Line Therapy in Patients With Metastatic Colorectal Cancer. [2011.11.20]
PURPOSE In a multicenter, double-blind phase II trial, we compared the efficacy and safety of perifosine plus capecitabine (P-CAP) with placebo plus capecitabine (CAP) in patients with metastatic colorectal cancer (mCRC) who had progressed after as many as two prior therapies.A phase III trial is underway comparing P-CAP with CAP in patients with refractory mCRC.
Preoperative radiotherapy with capecitabine and mitomycin C in locally advanced rectal carcinoma. [2011.09]
PURPOSE: To evaluate the efficacy and safety of preoperative radiotherapy with capecitabine and mitomycin C in patients with locally advanced rectal cancer... CONCLUSION: Preoperative chemoradiation with capecitabine and mitomycin C appeared to be effective with low toxicity in patients with locally advanced rectal cancer.
Clinical Trials Related to Xeloda (Capecitabine)
LBH589 in Combination With Capecitabine Plus/Minus (�) Lapatinib in Breast Cancer Patients [Completed]
This single center Phase I dose escalation trial will evaluate the safety, tolerability and
efficacy of LBH589 when combined with capecitabine and lapatinib in three parts. Part 1
will determine the maximum tolerated doses (MTD) of LBH589 when combined with capecitabine.
Parts 2 and 3 will be limited to locally recurrent or metastatic breast cancer patients,
ICH 3+ overexpression or FISH amplification documented locally. Part 2 will evaluate the
safety of the MTD of LBH589 determined in Part 1 when paired with lapatinib 1000 mg by mouth
(PO) daily. Parts 2 and 3 will be limited to locally recurrent or metastatic breast cancer
patients, ICH 3+ overexpression or FISH amplification documented locally. Part 3 will
evaluate the tolerability and effectiveness of the triplet combination, LBH589, capecitabine
and lapatinib in breast cancer patients.
A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors [Completed]
This study will evaluate the safety, tolerability, and pharmacokinetics of the combination
of rhuMab 2C4(Perjeta) and capecitabine (Xeloda) in participants with advanced solid tumors
that have progressed during or after standard therapy, or for which no standard therapy is
available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs)
in escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).
Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer [Active, not recruiting]
Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that
is HER2/neu-positive will take part in this study. This type of breast cancer has a high
amount of a protein called HER2. HER2 is part of a family of receptors found on both
cancer and normal cells. This family of receptors is important for cell growth and is found
in many tumor types. The purpose of this research study is to compare an approved treatment
for breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus
an experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or
metastatic breast cancer that is HER2/neu-positive. Capecitabine is an approved type of
chemotherapy used to treat certain cancers including breast cancer. Capecitabine fights
cancer by interfering with the ability of cells to divide and tumor growth. Lapatinib
(Tykerb®) is considered "investigational", which means the drug has not been approved by the
US Food and Drug Administration (FDA) for sale as a prescription or over-the-counter
medication. Lapatinib may slow or stop cancer cells from growing by inhibiting the growth of
cancer cells. However, this theory has not been proven. The addition of the study drug
(lapatinib) to capecitabine may help stop cancer cells as well as or better than
capecitabine alone. Other studies have demonstrated activity and tolerability of lapatinib
either alone or in combination with capecitabine in the treatment of breast cancer. Subjects
will receive capecitabine and lapatinib. A treatment period will be 21 days long. This
period is known as a "cycle". All medications will be given by mouth. Subjects will take
capecitabine for 2 weeks straight (Day 1-14) followed by a 1 week without capecitabine (Day
15-21). Doses of lapatinib will be taken daily continuously for 21 days (Day 1-Day 21)
which means that subjects will still take lapatinib on the week that they do not take
capecitabine (Day 15-21). Subjects will continue to receive these medications unless they
experience severe, serious and/or excessive side effects, the cancer becomes worse, the
subjects wishes to no longer participate or the study doctor feels it is not in the best
interest to continue treatment. Tests and procedures such as physical exam, blood tests, CT
or MRI, ECG, ECHO and/or MUGA tests will be conducted at one or more of the following time
points: before the study starts, before each cycle, every 6 and 12 weeks, and after the last
dose of capecitabine/lapatinib treatment.
Safety Study of a New Schedule of Capecitabine and Docetaxel to Treat Cancers [Completed]
The combination of capecitabine and docetaxel is given to treat several different types of
cancer. Capecitabine is usually given by mouth for 14 days, and docetaxel is given IV on
the first day of capecitabine. The effects of changes in the schedule of the combination of
docetaxel and capecitabine has been examined in human breast cancer cells. A capecitabine
by-product was given orally to breast cancer-bearing animals for 14 consecutive days.
Docetaxel was given IV at a variety of times between days 1 and 15. The greatest reductions
in the volume of the cancer were seen when animals were treated with docetaxel between days
6 and 10. In two other breast cancer models, the maximal degree of delay in growth of the
tumors was achieved when the animals were treated with docetaxel on day 8 of a 14 day course
of capecitabine. The extent of tumor response was not explained by changes in tumor levels
of the enzyme thymidine phosphorylase, which is thought to be the mechanism behind the
interaction of capecitabine and docetaxel. In the breast cancer cells, capecitabine
increases the level of proteins which promote death of cancer cells, and it inhibits the
levels of proteins which block death of cancer cells.
Our hypothesis is that capecitabine and docetaxel interact with each other, because
capecitabine primes the pro-death machinery of the cell by increasing the ratio of
death-promoting proteins to death-inhibiting proteins. Cells are more susceptible to
killing by docetaxel when the pro-death machinery is activated by capecitabine.
This is a safety study to find the highest dose of capecitabine that can be given safely for
14 days, in combination with docetaxel given at a fixed dose on day 8. Once this dose of
capecitabine has been determined, an additional nine patients with tumors that can be
biopsied will be treated at this dose, and levels of capecitabine, its byproducts, and
docetaxel will be measured in the bloodstream. Biopsies of tumors will also be taken before
and after the docetaxel is given, and the levels of pro-death and anti-death proteins will
A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer [Completed]
This study is for people with advanced cancer for which no curative treatment exists.
The purpose of this study is to test the safety and effectiveness of the combination of the
drugs Temsirolimus and Capecitabine and see what effects it has on cancer.
Temsirolimus is a drug that is given by vein that targets a protein important for the growth
of cancer cells known as mTOR. By inhibiting this protein, Temsirolimus can inhibit cancer
cell growth and even lead to their death.
Capecitabine is a more traditional chemotherapy. It is an oral pill that gets converted in
the body to the very common chemotherapy known as 5-fluorouracil.
This research is being done because it is not known if the combination of Temsirolimus and
Capecitabine will work better than Capecitabine or Temsirolimus alone.
Reports of Suspected Xeloda (Capecitabine) Side Effects
Palmar-Plantar Erythrodysaesthesia Syndrome (231),
Disease Progression (200),
Decreased Appetite (116),
Mucosal Inflammation (94), more >>
Page last updated: 2015-08-10