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 CLINICAL PHARMACOLOGY and 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 for the following:
Colorectal 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.
Breast Cancer Combination Therapy: XELODA in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
Breast Cancer Monotherapy: 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)
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.
Randomized phase 3 trial comparing preoperative and postoperative chemoradiotherapy with capecitabine for locally advanced rectal cancer. [2011.08.15]
BACKGROUND: Although many trials have shown the efficacy of preoperative chemoradiotherapy (CRT) or postoperative CRT compared with surgery alone, the optimal sequence of radiotherapy and surgery is unclear. The authors reported the final results of this single institution prospective randomized phase 3 trial comparing preoperative CRT with postoperative CRT using capecitabine in survival, local control, sphincter preservation, and toxicity for the treatment of locally advanced rectal cancer... CONCLUSIONS: Although significant benefit of preoperative CRT in local control and survival was not demonstrated, the data showed that increased rate of sphincter preservation was possible in low-lying tumors without jeopardizing local control and surgical complication by preoperative CRT. Copyright (c) 2011 American Cancer Society.
Correlation of capecitabine-induced skin toxicity with treatment efficacy in patients with metastatic colorectal cancer: results from the German AIO KRK-0104 trial. [2011.07.12]
BACKGROUND: The AIO KRK-0104 randomised phase II trial investigated the efficacy and safety of two capecitabine-based regimens: combination of capecitabine and irinotecan (CAPIRI) plus cetuximab (CAPIRI-C) and combination of capecitabine with oxaliplatin (CAPOX) plus cetuximab (CAPOX-C) in the first-line treatment of metastatic colorectal cancer (mCRC). Treatment-related skin toxicity (ST) was evaluated separately for capecitabine and cetuximab. The present analysis investigates the correlation of capecitabine-attributed ST (Cape-ST) and parameters of treatment efficacy... CONCLUSION: This analysis supports the hypothesis that for the evaluated regimens, a correlation exists between Cape-ST and treatment efficacy regarding DCR, PFS, and OS.
Impact of KRAS and BRAF Gene Mutation Status on Outcomes From the Phase III AGITG MAX Trial of Capecitabine Alone or in Combination With Bevacizumab and Mitomycin in Advanced Colorectal Cancer. [2011.07.01]
PURPOSE: Mutations affecting the KRAS gene are established predictive markers of outcome with anti-epithelial growth factor receptor (EGFR) antibodies in advanced colorectal cancer (CRC). The relevance of these markers for anti-vascular endothelial growth factor (VEGF) therapy is controversial. This analysis was performed to assess the predictive and prognostic impact of KRAS and BRAF gene mutation status in patients receiving capecitabine with bevacizumab (CG) or capecitabine without bevacizumab in the phase III AGITG MAX (Australasian Gastrointestinal Trials Group MAX) study... CONCLUSION: KRAS gene mutation status was neither prognostic for OS nor predictive of bevacizumab outcome in patients with advanced CRC. BRAF gene mutation status was prognostic for OS but was not predictive of outcome with bevacizumab.
Clinical Trials Related to Xeloda (Capecitabine)
Capecitabine (Xeloda) and Radiation for Patients With Rectosigmoid Carcinoma [Terminated]
This study is designed primarily to establish efficacy and estimate resource utilization. The
short-term hypothesis is that the dose of capecitabine (825 mg/m2 twice/day 5 days per week)
during the course of radiation therapy is efficacious in locally advanced, non-metastatic
rectosigmoid carcinoma and will improve resectability. The long-term working hypothesis is
that if 3-D CRT is combined with the potentiating and additive effect of capecitabine one
hopes to see improved and durable tumor response and survival with acceptable toxicity. In
addition, it is expected that the simplicity of using an oral agent (capecitabine) will be
associated with reduced cost and resource utilization.
XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer [Active, not recruiting]
XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with
metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be
randomized to standard XELOX (Capecitabine 1000 mg/mē in the morning and 1000 mg/mē in the
evening days 1-14 and short term Oxaliplatin 130 mg/mē day 1 in 30 minutes) or
chronomodulated XELOX (Capecitabine 400 mg/mē in the morning and 1600 mg/mē in the evening
days 1-14 and short term Oxaliplatin 130 mg/mē day 1 in 30 minutes).
Bloodsamples will be collected and frozen and later examined for potential predictive
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 be
Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer [Completed]
The purpose of this clinical research study is to learn if BMS-247550 added to the approved
therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine
alone in women with metastatic breast cancer. Patients should have previously received an
anthracycline and a taxane. The safety of this treatment will also be studied.
A Study of Capecitabine [Xeloda] and Concomitant Radiation Therapy in Children and Adolescent Patients With Newly Diagnosed Brainstem Glioma [Recruiting]
This open-label study will evaluate the progression-free survival, safety and
pharmacokinetics of capecitabine [Xeloda] rapidly disintegrating tablets and concomitant
radiation therapy in children and adolescent patients with newly diagnosed brainstem glioma.
Xeloda will be administered 650 mg/m2 orally twice daily during radiation phase (courses
1-3) followed by a two-weeks break and Xeloda will be administered 1250 mg/m2 during post
radiation (courses 4-6). During each course, Xeloda will be administered for 14 consecutive
days followed by a 7-days rest period. Dose can be adjusted according to toxicity and body
surface area. The anticipated time on study drug is 18 weeks.
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: 2011-12-09