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

Rectal Neoplasms Clinical Trial

Official title:

Treatment of Induction With XELOX-Bevacizumab in Locally Advanced Rectal Adenocarcinoma: Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00557713
• Other study ID #: AVACROSS
• Status: Recruiting
• Phase: Phase 2
• First received: November 13, 2007
• Last updated: November 13, 2007
• Start date: February 2007
• Est. completion date: October 2013

Study information

• Verified date: November 2007
• Source: Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Locally Advanced Rectal Adenocarcinoma
• Rectal Neoplasms

Intervention

Drug:
• bevacizumab
-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) -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)) -Surgery (6-8 weeks after last bevacizumab dose) -Adjuvant treatment: It will be individual decision of each investigator, but it's recommended 4 cycles of XELOX (equal dose at induction treatment)

Locations

Country	Name	City	State
Spain	ACROSS	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials	Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response Rate		after concomitant CT-RT treatment
Secondary	Complete Resection (R0) Rate		after surgery
Secondary	Disease Free Survival		from complete response to relapse or disease-related death
Secondary	Time to Failure Treatment		from first treatment dose to drop out of the study
Secondary	Metastatic or Local Recurrence		during study
Secondary	Toxicity Evaluation		during study
Secondary	Surgical Morbility		during surgery

External Links

•   across