Xeloda and Bevacizumab to Treat Rectal Cancer

Phase 2

Completed

• Conditions: Rectal Cancer
• Interventions: Biological: Bevacizumab; Drug: capecitabine (Xeloda); Radiation: Rectal Radiotherapy

• Registration Number: NCT00847119
• Lead Sponsor: Institut Català d'Oncologia

Brief Summary

The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and without distant metastases.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Primary Completion: 2011-06
• Study Completion: 2015-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1. The patient has given written informed consent prior to any study related procedure

2. Male and female aged 18 to 75 years

3. ECOG performance status 0 or 1

4. Histologically confirmed diagnostic of adenocarcinoma of the rectum < 15 cm from anal verge

5. Clinical stage of T3, T4 with/without regional lymph node metastases, without metastatic disease

6. Disease evaluable by imaging techniques

7. No tumour haemorrhage in the week prior to start of study treatment

8. External derivation in symptomatic occlusive tumours

9. Not prior cancer treatment

10. Adequate bone marrow, hepatic and renal function, defined as:

    1. White blood cells ≥ 4 x 109 /l
    2. Absolute neutrophil count ≥ 1.5 x 109 /l
    3. Platelets ≥ 100 x 109 /l
    4. Haemoglobin ≥10 g/dl
    5. Bilirubin < 1.25 x upper limit of normal
    6. Aspartate transaminase and alanine transaminase < 2.5 x upper limit of normal
    7. Serum creatinine ≤ 106 µmol/l

11. Less than 10% weight loss

Exclusion Criteria

1. Rectal cancer no amenable to resection

2. Any other malignancy which has been active or treated within the past 5 years , with the exception of in situ carcinoma of the cervix and non-melanoma skin lesions adequately treated

3. Pregnant or breast-feeding women

4. Women oh childbearing potential unless effective methods of contraception are used

5. No prior or concurrent significant medical conditions, including any of the following:

   • Cerebrovascular disease (including transient ischemic attack and stroke) within the past year
   • Cardiovascular disease, including the following:
   • Myocardial infarction within the past year
   • Uncontrolled hypertension while receiving chronic medication
   • Unstable angina
   • New York Heart Association class II-IV congestive heart failure
   • Serious cardiac arrhythmia requiring medication

6. Major trauma within the past 28 days

7. Serious nonhealing wound, ulcer, or bone fracture

8. Evidence of bleeding diathesis or coagulopathy

9. No lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication

10. No evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug

11. No known dihydropyrimidine dehydrogenase deficiency

12. Major surgery in the 4 weeks prior to the start of study treatment

13. No concurrent chronic, daily treatment with aspirin (> 325 mg/day)

14. More than 10 days since prior use of full-dose oral or parenteral anticoagulants for therapeutic purposes

15. No participation in another clinical trial with any investigational drug within 30 days prior to randomization or during study participation

16. No other medical history or condition that, in the opinion of the investigator, would preclude study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab & capecitabine & radiotheraphy	Bevacizumab	Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg. Radiotherapy 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week. Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period.
Bevacizumab & capecitabine & radiotheraphy	capecitabine (Xeloda)	Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg. Radiotherapy 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week. Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period.
Bevacizumab & capecitabine & radiotheraphy	Rectal Radiotherapy	Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg. Radiotherapy 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week. Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period.

Primary Outcome Measures

Name	Time	Method
Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece)	Surgery date

Secondary Outcome Measures

Name	Time	Method
Surgery complication rate	During surgery admission.
Overall clinical response	Surgery date
To determine the downstaging caused by treatment	Surgery date
relapse free survival	Time of radiological evidence of relapse.
Quantify the local control grade: R0 resections in surgery	Surgery date
Local relapse and distant relapse rates	Relapse date
To determine the security profile of this neoadjuvant treatment (radio- chemotherapy)	From date of register to surgery date
To determine the angiogenic profile changes in tumour.	15 days, 6 weeks and 4 months

Trial Locations

Locations (1)

Institut Català d'Oncologia-L'Hospitalet; 🇪🇸 L'Hospitalet del Llobregat, Barcelona, Spain