WARNING
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 SUMMARY
XELODA®
(capecitabine)
TABLETS
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.
|
NEWS HIGHLIGHTSMedia Articles Related to Xeloda (Capecitabine)
Breast Cancer Regimen Effective But Toxic (CME/CE)
Source: MedPage Today Hematology/Oncology [2009.11.10]
Adding capecitabine (Xeloda) to standard adjuvant chemotherapy significantly reduced the risk of breast cancer recurrence, but the cost was a substantial increase in adverse events, investigators in a randomized clinical trial reported.
Published Studies Related to Xeloda (Capecitabine)
A phase II trial evaluating capecitabine and irinotecan as second line treatment in patients with oesophago-gastric cancer who have progressed on, or within 3 months of platinum-based chemotherapy. [2009.08]
RATIONALE: There is no standard second line therapy for relapsed oesophago-gastric (O-G) cancer... CONCLUSIONS: Capecitabine and irinotecan has anti-tumour activity as second line treatment for relapsed O-G cancer, and provides an important improvement in disease related symptoms.
Comparing safety and efficacy of first-line irinotecan/fluoropyrimidine combinations in elderly versus nonelderly patients with metastatic colorectal cancer: findings from the bolus, infusional, or capecitabine with camptostar-celecoxib study. [2009.06.15]
BACKGROUND: Irinotecan-based chemotherapy regimens are 1 option for treatment of metastatic colorectal cancer (mCRC). The authors report the safety and efficacy of such regimens in elderly patients using a large phase III trial (bolus, infusional, or capecitabine with camptostar-celecoxib [BICC-C]) cohort... CONCLUSIONS: Irinotecan/fluoropyrimidine combinations are well tolerated in the elderly population, with similar efficacy to that found in nonelderly patients in first-line mCRC. (c) 2009 American Cancer Society.
Cost effectiveness of ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. [2009.05.01]
PURPOSE: Using data from a recent randomized trial, we evaluated the cost effectiveness of ixabepilone plus capecitabine versus capecitabine alone in patients with predominantly metastatic breast cancer considered to be taxane-resistant and previously treated with or resistant to an anthracycline... CONCLUSION: Addition of ixabepilone to capecitabine adds approximately $31,000 to overall medical costs and affords approximately 1 additional month of quality-adjusted survival.
Capecitabine plus Irinotecan (XELIRI regimen) compared to 5-FU/LV plus Irinotecan (FOLFIRI regimen) as neoadjuvant treatment for patients with unresectable liver-only metastases of metastatic colorectal cancer: a randomised prospective phase II trial. [2009.04.22]
BACKGROUND: Phase II studies have shown that the combination of capecitabine and irinotecan (the XELIRI regimen) is active in metastatic colorectal cancer (MCRC). There are, however, no data about the use of the XELIRI regimen in the neoadjuvant treatment... CONCLUSION: The XELIRI regimen showed similar ORR as the FOLFIRI regimen in the neoadjuvant treatment of patients with MCRC. In addition, the XELIRI regimen showed similar PFS and OS with acceptable toxicity compared to the FOLFIRI regimen. TRIAL REGISTRATION: Current Controlled Trials ISRCTN19912492.
Phase III study of gemcitabine plus docetaxel compared with capecitabine plus docetaxel for anthracycline-pretreated patients with metastatic breast cancer. [2009.04.10]
PURPOSE: Patients with metastatic breast cancer who are pretreated with anthracyclines frequently receive taxane-based combinations. This phase III study compared the efficacy and safety of gemcitabine-docetaxel (GD) with capecitabine-docetaxel (CD) in advanced breast cancer... CONCLUSION: No difference was observed between GD and CD arms in PFS, ORR, and OS. TTF was longer in the GD arm. These findings, combined with a nonhematologic toxicity profile that favors GD over approved doses of CD, suggest that gemcitabine may be a better option than capecitabine in combination with docetaxel in this clinical setting.
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/m² in the morning and 1000 mg/m² in the
evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or
chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening
days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes).
Bloodsamples will be collected and frozen and later examined for potential predictive
factors
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
measured.
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.
Capecitabine (XELODA) With Or Without Lapatinib(GW572016)For Women With Refractory Advanced or Metastatic Breast Cancer [Active, not recruiting]
This study was designed to compare the efficacy and safety of an oral dual tyrosine kinase
inhibitor in combination with capecitabine versus capecitabine alone in women with locally
advanced or metastatic breast cancer that has not responded to previous therapy.
|
|
|
|
Page last updated: 2009-11-10
|
