Xeloda and Bevacizumab to Treat Rectal Cancer

NCT ID: NCT00847119

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2015-02-28

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab & capecitabine & radiotheraphy

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.

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: BIOLOGICAL

Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.

capecitabine (Xeloda)

Intervention Type: DRUG

Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period

Rectal Radiotherapy

Intervention Type: RADIATION

Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.

Interventions

Bevacizumab

Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.

Intervention Type: BIOLOGICAL

capecitabine (Xeloda)

Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period

Intervention Type: DRUG

Rectal Radiotherapy

Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Institut Català d'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramon Salazar, Phd

Role: PRINCIPAL_INVESTIGATOR

Institut Català d'Oncologia

Margarita Garcia, MD

Role: STUDY_CHAIR

Institut Català d'Oncologia

Locations

Institut Català d'Oncologia-L'Hospitalet

L'Hospitalet Del Llobregat, Barcelona, Spain

Countries

Spain

References

Garcia M, Martinez-Villacampa M, Santos C, Navarro V, Teule A, Losa F, Pisa A, Cambray M, Soler G, Lema L, Kreisler E, Figueras A, Juan XS, Vinals F, Biondo S, Salazar R. Phase II study of preoperative bevacizumab, capecitabine and radiotherapy for resectable locally-advanced rectal cancer. BMC Cancer. 2015 Feb 26;15:59. doi: 10.1186/s12885-015-1052-0.

Reference Type: RESULT

PMID: 25886275 (View on PubMed)

Other Identifiers

EudraCT number:2007-000456-13

Identifier Type: -

Identifier Source: secondary_id

ML 20006. XEBERECTO/ICO/005

Identifier Type: -

Identifier Source: org_study_id