Phase 2
N=43
A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01227707 ↗Enrolled (actual)
43
Serious AEs
19.1%
Results posted
Aug 2014
Primary outcome: Primary: Percentage of Participants With Pathological Complete Response (pCR) — 10.00 percentage of participants — p=1.00
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab [Avastin] (Drug); capecitabine [Xeloda] (Drug); Radiation therapy (Radiation); Mesorectal excision (Procedure); 5-fluorouracil (Drug); leucovorin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Pathological Complete Response (pCR) |
10.00 | 1.00 |
| SECONDARY Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT) |
0; 4.65; 0; 4.65; 0; 2.33 | — |
| SECONDARY Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure |
70.0; 22.5; 3.0; 47.50; 32.50; 20.0 | — |
| SECONDARY Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment |
11.63; 18.60 | — |
| SECONDARY Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment |
9.30 | — |
| SECONDARY Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment |
4.65 | — |
| SECONDARY Percentage of Participants With Relapse During Follow-Up |
84.21; 7.89; 7.89 | — |
| SECONDARY Disease-Free Survival (DFS) - Percentage of Participants With an Event |
30.23 | — |
| SECONDARY DFS - Time to Event |
27.43 | — |
| SECONDARY Overall Survival (OS) - Percentage of Participants With an Event |
25.58 | — |
| SECONDARY OS - Time to Event |
32.14 | — |
| SECONDARY Time to Disease Progression (TTP) - Percentage of Participants With an Event |
27.91 | — |
| SECONDARY TTP - Time to Event |
27.68 | — |
Summary
This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer. Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2 weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation therapy. After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the discretion of the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months will be given.
Eligibility Criteria
Inclusion Criteria
- Adult patients, >=18 years of age
- Patients with confirmed rectal cancer who are subject to surgery and would benefit from pre-operative combined chemo-radiotherapy
- Measurable and/or evaluable lesions according to RECIST criteria
- EOCG performance status 0-1
Exclusion Criteria
- Prior radiotherapy or chemotherapy for rectal cancer
- Untreated brain metastases or spinal cord compression or primary brain tumors
- Chronic daily treatment with high-dose aspirin (>325 mg/day) or other medications known to predispose to gastrointestinal ulceration
- Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ.
Data sourced from ClinicalTrials.gov (NCT01227707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.