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A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01227707
First received: October 22, 2010
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
 Drug: bevacizumab [Avastin]
Drug: capecitabine [Xeloda]
Radiation: Radiation therapy
Procedure: Mesorectal excision
Drug: 5-fluorouracil
Drug: leucovorin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pathological complete response rate (pCR) after chemo-radiotherapy (histologic tumour assessment by local and central pathologist) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical tumour and lymph node response to chemo-radiotherapy (assessments by endosonography, rectosigmoidoscopy, pelvic and abdomen CT scan or MRI) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Sphincter-saving procedure rate after pre-operative chemo-radiotherapy [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Disease-free survival (tumor assessments by endosonography, rectosigmodoscopy and pelvic and abdomen CT scan or MRI) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: November 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: bevacizumab [Avastin]
5 mg/kg intravenously every 2 weeks, 4 cycles
Drug: capecitabine [Xeloda]
825 mg/m2 twice daily orally, 38 days
Radiation: Radiation therapy
Total dose of 45 Gy over 38 days
Procedure: Mesorectal excision
6-8 weeks after completion of neoadjuvant treatment
Drug: bevacizumab [Avastin]
Post-surgery adjuvant treatment at the discretion of the investigator: 5 mg/kg iv every 2 weeks for at least 6 months
Drug: 5-fluorouracil
Post-surgery adjuvant therapy: bolus of 400mg/m2 iv plus iv infusion of 600 mg/m2 on Days 1 and 2 of each 2-week cycle for 6 months
Drug: leucovorin
Post-surgery adjuvant treatment: 100 mg/m2 iv on Days 1 and 2 of each 2-week cycle for 6 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227707

Locations
Italy
Ancona, Italy, 60121
Bologna, Italy, 40139
Cuneo, Italy, 12100
Genova, Italy, 16132
Napoli, Italy, 80131
Paola, Italy, 87027
Pisa, Italy, 56100
Roma, Italy, 00135
Siena, Italy, 53100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01227707     History of Changes
Other Study ID Numbers: ML18522
Study First Received: October 22, 2010
Last Updated: June 3, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Fluorouracil
Capecitabine
Bevacizumab
 Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 18, 2013