Clinical Trial Results: Xeloda [capecitabine]

Product Name: Xeloda [capecitabine]
Date of Report: 3/2/2001
Phase: III
An Open-Label Randomized Phase III Study of Capecitabine in Combination with Docetaxel (Taxotere) Versus Docetaxel Monotherapy in Patients with Advanced and/or Metastatic Breast Cancer

Product Name: Xeloda [capecitabine]
Date of Report: 4/23/2003
Phase: II
A Phase 2 study on the use of capecitabine in patients ≥65 years with advanced breast cancer

Product Name: Xeloda [capecitabine]
Date of Report: 2/16/2004
Phase: II
An Open-Label, Phase II Study of Capecitabine in Combination with Oxaliplatin as First-Line Treatment for Patients with Advanced and/or Metastatic Colorectal Cancer

Product Name: Xeloda [capecitabine]
Date of Report: 3/2/2004
Phase: II
An open-label Phase II study of intermittent oral capecitabine in the first-line treatment of patients with metastatic colorectal cancer

Product Name: Xeloda [capecitabine]
Date of Report: 5/10/2004
Phase: IV
A Phase II study of capecitabine (Ro 09-1978) in patients with metastatic breast cancer, who relapsed after treatment with a taxane-containing chemotherapy.

Product Name: Xeloda [capecitabine]
Date of Report: 7/26/2004
Phase: II
A dose-finding study of capecitabine (Ro 09-1978) in combination with standard radiotherapy in head and neck cancer patients

Product Name: Xeloda [capecitabine]
Date of Report: 8/31/2004
Phase: III
An open-label, randomized, phase III study comparing Xeloda (capecitabine) with iv bolus 5-fluorouracil in combination with low-dose leucovorin as adjuvant chemotherapy in patients who underwent surgery for Dukes C colon cancer

Product Name: Xeloda [capecitabine]
Date of Report: 10/1/2004
Phase: II
Phase I/II study of the combination capecitabine and vinorelbine as chemotherapy for metastatic breast cancer.

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: III
A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: III
A Study to Assess Xeloda (Capecitabine) in Patients With Locally Advanced or Metastatic Breast Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: III
A Study of Capecitabine (Xeloda) Plus Oxaliplatin in Patients With Colon Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: IV
A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: IV
A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: IV
XeNA study A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
SOCRATES study A Study of Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
A Study of Xeloda (Capecitabine) in Patients With Metastatic or Locally Advanced Breast Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
A Study of Xeloda (Capecitabine) Prior to Surgery in Women With Breast Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: III
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: III
A Study of Xeloda (Capecitabine) in Patients With Advanced or Metastatic Gastric Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
A Study of Xeloda (Capecitabine) and PEGASYS® in Treatment-Naïve Patients With Advanced Liver Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Metastatic Nasopharyngeal Cancer

Product Name: Xeloda [capecitabine]
Date of Report: 10/26/2005
Phase: IV
An open-label, randomized, phase III study of capecitabine in combination with docetaxel vs capecitabine followed by docetaxel as first-line treatment for metastatic breast cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
A Study of Xeloda (Capecitabine) Plus Radiotherapy in Patients With Rectal Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
A Study of Xeloda (Capecitabine) in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
A Study of Xeloda (Capecitabine) plus Radiotherapy in Patients With Locally Advanced Cervical Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: IV
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

Product Name: Xeloda [capecitabine]
Date of Report: 11/1/2005
Phase: II
A phase II study of oral Xeloda (capecitabine) in combination with intravenous irinotecan for patients with locally advanced and/or metastatic colorectal cancer (ROXI trial).

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
A Study of Xeloda (Capecitabine) Combined With Standard Radiotherapy in Patients With Locally Advanced Rectal Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: IV
A Study of Xeloda (Capecitabine) in the Adjuvant Treatment of Patients With Resected Colon Cancer

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: III
A Study of Xeloda (capecitabine) in Combination Chemotherapy Versus Surgery Alone in Patients With Gastric Cancer

Product Name: Xeloda [capecitabine]
Date of Report: 11/21/2006
Phase: II
An open-label phase II study of intermittent oral capecitabine in combination with docetaxel (q3w) in patients with advanced and/or metastatic breast cancer.

Product Name: Xeloda [capecitabine]
Date of Report: 12/1/2006
Phase: III
An open label multi-center trial to assess the pharmacokinetic interaction between capecitabine and oxaliplatin in patients with metastatic colorectal cancer.

Product Name: Xeloda [capecitabine]
Date of Report: 2/1/2007
Phase: III
2 x 2 Factorial randomized phase III study of intermittent oral capecitabine in combination with intravenous oxaliplatin (q3w) ("XELOX") with/without intravenous bevacizumab (q3w) versus bolus and continuous infusion fluorouracil/intravenous leucovorin with intravenous oxaliplatin (q2w) ("FOLFOX-4") with/without intravenous bevacizumab (q2w) as first-line treatment for patients with metastatic colorectal cancer.

Product Name: Xeloda [capecitabine]
Date of Report: 2/1/2007
Phase: III
An open-label randomized phase III study of intermittent oral capcitabine in combination with intravenous oxaliplatin (Q3W) ("XELOX") versus bolus and continuous infusion fluorouracil/intravenous leucovorin with intravenous oxaliplatin (Q2W) ("FOLFOX4") as treatment for patients with metastatic colorectal cancer who have received prior treatment with irinotecan in combination with 5-FU/LV as first line therapy.

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients WIth Metastatic Nasopharyngeal Cancer.

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.

Product Name: Xeloda [capecitabine]
Date of Report: 6/15/2007
Phase: III
A phase III study comparing taxotere, epirubicin and Xeloda (TEX) versus epirubicin and taxotere (ET) in advanced breast cancer patients.

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: IV
A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.

Product Name: Xeloda [capecitabine]
Date of Report: 9/3/2007
Phase: II
A Phase II Study of Capecitabine plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer.

Product Name: Xeloda [capecitabine]
Date of Report: 9/3/2007
Phase: II
An open-label phase II study of continuous oral capecitabine in combination with weekly irinotecan in patients with advanced and/or metastatic colorectal cancer.

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: I
A Study of Xeloda (Capecitabine) plus Radiation Therapy in Children With Newly Diagnosed Gliomas.

Product Name: Xeloda [capecitabine]
Date of Report: 1/15/2008
Phase: II
An open-label phase II study to analyze the efficacy and tolerability of capecitabine in metastatic colorectal cancer patients with regards to the expression profile of key enzymes in the capecitabine metabolism.

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: III
A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated WIth Oral Xeloda (Capecitabine).

Product Name: Xeloda [capecitabine]
Date of Report: To be Published
Phase: II
A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer.