A double-blind, randomised, multicenter, phase III study ofbevacizumab in combination with capecitabine and cisplatinversus placebo in combination with capecitabine and cisplatin, asfirst-line therapy in patients with advanced gastric cancer. - ND

• Conditions: Patients with inoperable, locally advanced or metastaticadenocarcinoma of the stomach or gastro-oesophageal junction,who have received no prior treatment for advanced or metastatic gastric cancer.; MedDRA version: 9.1Level: LLTClassification code 10017758Term: Gastric cancer

• Registration Number: EUCTR2007-000175-42-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-09
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 760

Inclusion Criteria

1. Written informed consent obtained prior to any study specific procedures.

2. Age ≥ 18 years

3. ECOG PS of 0, 1 or 2

4. Life expectancy of at least 3 months

5. Able to comply with the protocol

6. Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction* with

inoperable, locally advanced or metastatic disease, not amenable to curative therapy.

*Adenocarcinoma of gastro-oesophageal junction (GOJ) is defined as tumours that have their centre within 5 cm proximal and distal of the anatomical cardia as described in Siewert?s

classification system.

7. Measurable disease or non-measurable but evaluable disease, according to the Response

Evaluation Criteria in Solid Tumours (RECIST). Patients with peritoneal disease would generally

be regarded as having evaluable disease and allowed to enter the trial.

8. Patient not receiving anticoagulant medication must have an INR ≤ 1.5 and aPTT ≤ 1.5 x ULN

within 7 days prior to randomisation.*

*The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is

within therapeutic limits (according to the medical standard in the institution) and the patient has

been on a stable dose of anticoagulants for at least two weeks at the time of randomisation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Previous chemotherapy for locally advanced or metastatic gastric cancer. Patients may have received prior neoadjuvant or adjuvant chemotherapy as long as it was completed at least 6

months prior to randomisation.

2. Previous platinum or anti-angiogenic therapy (i.e. anti-VEGF or VEGFR tyrosine kinase inhibitor

etc).

3. Patients with locally advanced disease who are candidates for curative therapy (including

operation and/or chemotherapy and/or radiotherapy).

4. Radiotherapy within 28 days of randomisation. Patients given palliative radiotherapy to peripheral

sites (e.g. bone metastasis) may enter the study before 28 days have elapsed but must have recovered from any acute, reversible effects.

5. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomisation,

or anticipation of the need for major surgery during the course of the study treatment (planned elective surgery).

6. Minor surgical procedures within 2 days prior to randomisation (including CVAD placement for chemotherapy administration).

7. Evidence of CNS metastasis at baseline. A CT or MRI scan within 28 days prior to randomisation

is mandatory to exclude CNS involvement in case of clinical suspicion of CNS metastasis.

8. History or evidence upon physical/neurological examination of CNS disease unrelated to cancer

unless adequately treated with standard medical therapy, e.g. uncontrolled seizures.

9. History of another malignancy which could affect compliance with the protocol or interpretation

of results. Patients are generally eligible if they have had non-melanomatous cancer of the skin,

carcinoma in situ of the cervix, or another malignancy treated with curative intent if they have

been disease-free for more than 5 years.

10. Inadequate bone marrow function: ANC < 1.5 x 109/L, platelet count < 100 x 109/L or Hb < 9 g/dL.

11. Inadequate liver function: serum (total) bilirubin > 1.5 x ULN, AST & ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases), alkaline phosphatase > 2.5 x ULN or > 5 x ULN in case of liver metastases or > 10 x ULN in case of bone metastases.

12. Inadequate renal function:

Creatinine clearance should be ≥ 60 mL/min. The Cockroft and Gault formula is recommended for calculation of creatinine clearance. Patients with a creatinine clearance just below 60 ml/min may be eligible if a measured creatinine clearance (based on 24 hour urine collection or other reliable method) is ≥ 60 mL/min.

Urine dipstick for proteinuria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr.

13. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically

significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents (≤ 6 months

prior to randomisation), myocardial infarction (≤ 6 months prior to randomisation), unstable angina, New York Heart Association Grade II or greater congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment.

etc...

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare overall survival;Secondary Objective: - To compare progression-free survival, progression free<br><br>survival during first line therapy, time to progression,<br><br>overall response rate, duration of response during first<br><br>line therapy and disease control rate in the two treatment<br><br>groups<br><br><br><br>- To compare the safety profile in the two treatment<br><br>groups;Primary end point(s): The primary efficacy endpoint for this study is overall survival (time to death), defined as the time between randomisation and the date of death irrespective of the cause of death.