Clinical trial NCT01227707: A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.
Official title: An Open-label Study to Assess the Effect of Combination Treatment With Avastin and Xeloda, Plus Pre-operative Standard Radiotherapy, on Response Rate in Patients With Locally Advanced Rectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-10-25
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Percentage of Participants With Pathological Complete Response (pCR)
timeFrame: 6 to 8 weeks following completion of neoadjuvant treatment
Secondary outcomes:
measure: 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)
timeFrame: Baseline (BL) and end of neoadjuvant treatment (within 6 weeks after the completion of study treatment)
measure: Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure
timeFrame: 6 to 8 weeks after completion of study treatment
measure: Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment
timeFrame: BL and within 6 weeks after the completion of study treatment
measure: Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment
timeFrame: BL and within 6 weeks after the completion of study treatment
measure: Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment
timeFrame: BL and within 6 weeks after the completion of study treatment
measure: Percentage of Participants With Relapse During Follow-Up
timeFrame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
measure: Disease-Free Survival (DFS) - Percentage of Participants With an Event
timeFrame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
measure: DFS - Time to Event
timeFrame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
measure: Overall Survival (OS) - Percentage of Participants With an Event
timeFrame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
measure: OS - Time to Event
timeFrame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
measure: Time to Disease Progression (TTP) - Percentage of Participants With an Event
timeFrame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
measure: TTP - Time to Event
timeFrame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
Other outcomes:
Locations:
city: Ancona
country: Italy
city: Bologna
country: Italy
city: Cuneo
country: Italy
city: Genova
country: Italy
city: Napoli
country: Italy
city: Paola
country: Italy
city: Pisa
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: