Safety and Efficacy Study to Compare Capecitabine + Bevacizumab Versus Capecitabine, Concomitantly With Radiotherapy as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer

Rectal Cancer Clinical Trial

— AVAXEL  

Official title:

Phase II Randomized Study to Compare Capecitabine + Bevacizumab Concomitantly With Radiotherapy Versus Capecitabine Concomitantly With Radiotherapy, as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043484
• Other study ID #: TTD-08-05
• Secondary ID: EudraCT: 2009-01
• Status: Completed
• Phase: Phase 2
• First received: December 30, 2009
• Last updated: October 18, 2016
• Start date: December 2009
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the efficacy and safety of the combination of capecitabine + bevacizumab concomitantly with radiotherapy versus capecitabine concomitantly with radiotherapy, as neoadjuvant treatment for patients with localized and resectable rectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2016
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent

• Age =18 years

• ECOG = 1

• Histologically confirmed carcinoma of the rectum

• Localized and resectable rectal cancer

• No metastatic disease

• Measurable disease

• Life expectancy more than 4 months

• Non prior treatment for rectal cancer

• Adequate haematological function: leu = 4x 109 /l, Hb =10 gr/dl, neutropils= 1,5 x 109 /l and platelets =100 x 109 /l

• Adequate renal function: creatinine = 106 umol/l or calculated creatinine clearance > 50 mL/min

• Adequate liver function: AST, ALT and alkaline phosphatase =2.5 x UL, bilirubin =1.5 x UL

• Adequate nutritional weight loss <10% of regular weight and albumin = 35 g/l

Exclusion Criteria:

• Unresectable rectal cancer

• Past or current history (within the last 5 years prior to treatment start) of other malignancies.

• Patients of childbearing potential not willing to use effective means of contraception.

• Clinically significant cardiovascular disease

• Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication.

• Patients subjected to organ allografts who require immunosuppressive treatment.

• Severe, non-cicatrized osseous fractures, wounds or ulcers.

• Indications of hemorrhagic diathesis or coagulopathy.

• Severe, uncontrolled intercurrent infections or other severe, uncontrolled concomitant diseases.

• History of unexpected severe reactions to treatment with fluoropyrimidines or known deficiency dihydropyrimidine dehydrogenase deficiency (DPD).

• Patients subjected to a major surgical procedure, open biopsy or who have had significant traumatic lesions within the 28 days prior to beginning the treatment of the study or in whom it is foreseen that a major surgical procedure will be necessary during the course of the study; fine-needle aspiration within the 7 days prior to beginning the treatment of the study.

• Current or recent use (within the 10 days prior to beginning the treatment of the study) of oral or parenteral anticoagulants at complete doses or thrombolytic agents. The use of low doses of warfarin is allowed, with an International Normalized Ratio [INR] of < 1.5.

• Daily chronic treatment with high doses of aspirin (> 325 mg/day) or non-steroid anti-inflammatory medications (which inhibit the platelet function at doses used for treating chronic inflammatory diseases).

• Patients who have received any drug or agent/procedure under research, i.e., who have participated in another clinical trial during the 4 weeks prior to beginning the treatment with the medications of the study

• Any psychological, familiar conditions suggesting that the patient will not be able to complete the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Bevacizumab + Capecitabine + Radiotherapy
Bevacizumab (5 mg/kg; days 1, 15 and 29) Capecitabine (825 mg/m2/12h, 5 days/w) Radiotherapy (45 Gy in sessions of 1.8 Gy 5 times/w for 5 weeks)
• Capecitabine + Radiotherapy
Capecitabine (825 mg/m2/12h, 5 days/w) and Radiotherapy (45 Gy in sessions of 1.8 Gy 5 times/w for 5 weeks)

Locations

Country	Name	City	State
Spain	Spanish Cooperative Group for Gastrointestinal Tumour Therapy	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)	Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate complete pathologic responses		17 months	No
Secondary	Disease free survival at 3 and 5 years		78 months	No
Secondary	Rate of local and distant recurrence at 3 and 5 years		78 months	No
Secondary	Overall survival at 3 and 5 years		78 months	No
Secondary	R0 resection rate.		17 months	No
Secondary	Adverse events		17 months	Yes
Secondary	Rate of surgery complications		17 months	Yes
Secondary	Molecular predictive markers: changes in angiogenic parameters, vascular endothelial growth factor (VEGF), vascular endothelial growth factor receptors, microvessel quantification and angiopoietin-2 (Ang-2)		17 months	No
Secondary	Rate of sphincter preservation		17 months	No

External Links

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