A Phase I/II Study Evaluating the Combination of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in Patients With Advanced Gastric Cancer
1. Patients above 18 years of age at the time of enrollment.
2. Histologically confirmed previously untreated metastatic or unresectable
adenocarcinoma of the stomach.
3. Patients must have at least one measurable lesion (measuring >10mm in standard CT or
>5mm in spiral CT).
4. Adequate organ function.
5. Life expectancy of at least three months.
6. Patients must have an ECOG Performance Status of 0 or 1.
7. Signed written informed consent to participate in the study.
1. Participation in an investigational trial within 30 days of the screening visit.
2. Known allergy or any other adverse reaction to any of the study drugs or to any
3. Prior anti-angiogenic treatment, chemotherapy or radiotherapy for advanced disease.
Patients will be eligible if they had received adjuvant chemotherapy or radiotherapy
more than 12 months prior to enrollment.
4. Prior treatment with drugs included in the investigational regimen. Prior use of
5-fluorouracil in the adjuvant setting is allowed.
5. Significant bleeding by the primary tumor (in unoperated patients).
6. Clinically significant (i.e. active) cardiovascular disease. This includes, but is
not limited to, the following examples:
- Cerebrovascular accidents (up to 6 months prior to randomization)
- Myocardial infarction (up to 1 year prior to randomization).
- Uncontrolled hypertension (above 150/100 mmHg) while receiving chronic
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- Serious cardiac arrhythmia requiring medication.
- Clinically significant ECG findings. Patients who suffer from serious cardiac
arrhythmia requiring medication can enter the study only if they are considered
to be in a stable condition regarding both the arrhythmia and their medication.
Patients with pacemakers are allowed to enter the study only if they are
considered as being in a stable condition. In case of doubt, the investigator
should obtain a consultation with a local cardiologist.
7. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study treatment start, not fully healed wounds, or anticipation of the need
for major surgical procedure during the course of the study.
8. Severe co-morbid conditions including uncontrolled diabetes or hypertension, cerebral
vascular disease or uncontrolled infection.
9. Fertile subjects who are not willing to use an acceptable method of contraception
during the treatment period and for 28 days following completion of treatment
10. For women of child-bearing potential: a positive pregnancy test at screening or
11. History of prior malignancy (other than non-melanoma skin cancer, in-situ cervical
cancer, or superficial transitional cell bladder cancer) in the last 5 years prior to
12. Clinically significant hearing loss.
13. Patients with a history of seizure disorder who are receiving phenytoin,
phenobarbital, or other antiepileptic medication.
14. Known peripheral neuropathy of CTCAE v 3.0 Grade 1 or more.
15. Organ allografts requiring immunosuppressive therapy.
16. Serious, non-healing wound, ulcer, or bone fracture.