| September 15, 2003 |
| October 15, 2009 |
| July 2003 |
| |
| Non-inferiority of XELOX vs FOLFOX, with respect to time to progression or death, and superiority of Avastin vs placebo. [ Time Frame: Event driven ] [ Designated as safety issue: No ] |
| Efficacy: Non-inferiority of XELOX vs FOLFOX with respect to time to tumor progression or death, and superiority of Avastin vs placebo |
| Complete list of historical versions of study NCT00069095 on ClinicalTrials.gov Archive Site |
- Overall survival, overall response rate, time to response, duration of response, time to treatment failure. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- AEs, laboratory tests. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|
- Efficacy: Overall survival, overall response rate, time to response, duration of response, time to treatment failure
- Safety: Adverse events, laboratory tests
|
| |
| A Study of Xeloda (Capecitabine) as a First-Line Therapy in Patients With Metastatic Colorectal Cancer |
| A Randomized, Open-label Study Comparing the Effect of First-line Treatment With Intermittent Xeloda Versus Fluorouracil/Leucovorin, Both in Combination With Eloxatin With or Without Avastin, on Tumor Progression in Patients With Metastatic Colorectal Cancer |
This 4 arm study will assess the efficacy and safety of oral Xeloda, or intravenous (iv) fluorouracil/leucovorin, in combination with iv Eloxatin (oxaliplatin) with or without iv Avastin as a first-line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin), in 3 week cycles, 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles), 3) XELOX + Avastin (7.5 mg iv on day 1)in 3 week cycles or 4)FOLFOX-4 + Avastin (5mg iv on day 1)in 2 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study |
| Colorectal Cancer |
- Drug: capecitabine [Xeloda]
- Drug: Oxaliplatin
- Drug: Leucovorin
- Drug: 5 FU
- Drug: Avastin
|
| |
| |
| |
| Active, not recruiting |
| 2035 |
| December 2009 |
|
Inclusion Criteria:
- adult patients >=18 years of age;
- metastatic colorectal cancer;
- >=1 target lesion.
Exclusion Criteria:
- previous treatment with oxaliplatin or bevacizumab;
- previous systemic chemotherapy or immunotherapy for advanced or metastatic disease;
- progressive disease during or within 6 months of completion of previous adjuvant therapy.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Australia, Austria, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Republic of, Mexico, New Zealand, Norway, Panama, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom |
| |
| NCT00069095 |
| Disclosures Group, Hoffmann-La Roche |
| NO16966 |
| Hoffmann-La Roche |
|
| Study Director: |
Clinical Trials |
Hoffmann-La Roche |
|
|
| Hoffmann-La Roche |
| October 2009 |
