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XELOX+Bevacizumab Followed by Capecitabine+Bevacizumab+Radiotherapy as Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma

This study is currently recruiting participants.
Verified November 2007 by Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
ClinicalTrials.gov Identifier:
NCT00557713
First received: November 13, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

The purpose of this study is to determine the pathological complete response rate of addition of bevacizumab to induction therapy (xelox) and concomitant treatment (capecitabine+radiotherapy), followed by surgery.


Condition Intervention Phase
Rectal Neoplasms
Locally Advanced Rectal Adenocarcinoma
 Drug: bevacizumab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Induction With XELOX-Bevacizumab in Locally Advanced Rectal Adenocarcinoma: Phase II Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials:

Primary Outcome Measures:
  • Pathologic Complete Response Rate [ Time Frame: after concomitant CT-RT treatment ]

Secondary Outcome Measures:
  • Complete Resection (R0) Rate [ Time Frame: after surgery ]
  • Disease Free Survival [ Time Frame: from complete response to relapse or disease-related death ]
  • Time to Failure Treatment [ Time Frame: from first treatment dose to drop out of the study ]
  • Metastatic or Local Recurrence [ Time Frame: during study ]
  • Toxicity Evaluation [ Time Frame: during study ]
  • Surgical Morbility [ Time Frame: during surgery ]

Estimated Enrollment: 44
Study Start Date: February 2007
Estimated Study Completion Date: October 2013
Arms Assigned Interventions
Experimental: A
  1. -Induction treatment. 4 cycles (every 3 weeks) of bevacizumab (7,5mg/kg day 1) + oxaliplatin (130mg/m2 day 1) + capecitabine (1000mg/m2/12h days 1-14)
  2. -Concomitant (CT+RT) treatment (3 weeks later): bevacizumab (5mg/kg day 1 of 1st, 3th and 5th weeks) + capecitabine (825mg/m2/12h daily during radiotherapy treatment) + radiotherapy (45Gy (25fractions of 1,8Gy/day over 5weeks) followed by boost 5.4Gy (1,8Gy/day over 3days))
  3. -Surgery (6-8 weeks after last bevacizumab dose)
  4. -Adjuvant treatment: It will be individual decision of each investigator, but it's recommended 4 cycles of XELOX (equal dose at induction treatment)
 Drug: bevacizumab
  1. -Induction treatment. 4 cycles (every 3 weeks) of bevacizumab (7,5mg/kg day 1) + oxaliplatin (130mg/m2 day 1) + capecitabine (1000mg/m2/12h days 1-14)
  2. -Concomitant (CT+RT) treatment (3 weeks later): bevacizumab (5mg/kg day 1 of 1st, 3th and 5th weeks) + capecitabine (825mg/m2/12h daily during radiotherapy treatment) + radiotherapy (45Gy (25fractions of 1,8Gy/day over 5weeks) followed by boost 5.4Gy (1,8Gy/day over 3days))
  3. -Surgery (6-8 weeks after last bevacizumab dose)
  4. -Adjuvant treatment: It will be individual decision of each investigator, but it's recommended 4 cycles of XELOX (equal dose at induction treatment)
Other Name: Avastin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent from patients who are able to understand the study request
  • Histologically confirmed diagnosis of locally advanced rectal adenocarcinoma; ≤12 cm from the anal margin; T3, operable T4 or TxN+
  • Karnofsky PS Index ≥ 70%
  • Life expectancy > 6 months
  • Adequate bone marrow, liver and renal function: ANC ≥ 1.5 x 10e9/l; Platelets ≥ 100 x 10e9/l; Hb ≥ 9g/dl; INR ≤ 1.5; Bilirubin ≤ 1.5 x ULN; ALT and/or AST ≤ 2.5 x ULN or ≤ 5 x ULN (in case of hepatic metastasis); Alkaline phosphatase ≤ 2.5 x ULN or ≤ 5 x ULN (in case of hepatic metastasis) or ≤ 10 x ULN (in case of bone metastasis); Creatinine clearance (Cockcroft-Gault) ≥ 30 ml/min or seric creatinine ≤ 1.5 x ULN

Exclusion Criteria:

  • Distant metastases; previous neoplasm during last 5 years or previous infiltrating neoplasm; previous treatment with radiotherapy or study drugs; recruited for other clinical trial in 4 weeks before study entry
  • Surgery, open biopsy or traumatic injury in 4 weeks before study entry; fine-needle aspiration in 7 days before study entry; major surgery planned during study
  • Previous heart disease or uncontrolled hypertension, previous hemorrhagic diathesis or coagulopathy; full-dose oral or parenteral anticoagulant or thrombolytic agent (low-dose warfarin is allowed, INR ≤ 1.5); chronic use of high-dose aspirin (<325mg/day) or non-steroidal anti-inflammatory treatment
  • No integrity of the upper gastrointestinal tract, malabsorption syndrome or unable to take oral drugs
  • Pregnant or lactating patients; SNC disease; allogeneic transplant with immunosuppressive drugs; bone fracture not healed, wound or severe ulcers; uncontrolled intercurrent severe infections; previous related-fluoropyrimide SAEs or DPD deficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557713

Locations
Spain
ACROSS Recruiting
Barcelona, Spain, 08021
Contact: Inmaculada Portal, MD         inmaportal@teleline.es    
Principal Investigator: Miquel Nogué, MD            
Principal Investigator: Bernardo Queralt, MD            
Principal Investigator: Carles Pericay, MD            
Principal Investigator: Ferran Losa, MD            
Principal Investigator: Isabel Moreno, MD            
Principal Investigator: José María Roca, MD            
Principal Investigator: Pilar Vicente, MD            
Principal Investigator: Christian Rolfo, MD            
Principal Investigator: Inmaculada Guasch, MD            
Principal Investigator: Antonio Arriví, MD            
Principal Investigator: Enrique Cabrera, MD            
Principal Investigator: María José Safont, MD            
Principal Investigator: Gaspar Esquerdo, MD            
Principal Investigator: Ana Ruiz, MD            
Principal Investigator: Antonieta Salud, MD            
Sponsors and Collaborators
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
Hoffmann-La Roche
Investigators
Study Chair: Miquel Nogué, MD Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
  More Information

Additional Information:
across  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00557713     History of Changes
Other Study ID Numbers: AVACROSS
Study First Received: November 13, 2007
Last Updated: November 13, 2007
Health Authority: Spain: Ethics Committee
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Neoplasms
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Cystic, Mucinous, and Serous
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
 Intestinal Diseases
Rectal Diseases
Capecitabine
Bevacizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013