A Phase II Study of Capecitabine, Carboplatin, and Bevacizumab for Metastatic or Unresectable Gastroesophageal Junction and Gastric Adenocarcinoma
To investigate bevacizumab in combination with carboplatin and capecitabine for patients with unresectable or metastatic GEJ or gastric cancers. We hope that by adding bevacizumab to standard chemotherapy for this patient population we will improve Progression Free Survival by 80% over historical controls.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : bevacizumab
- drug : capecitabine
- drug : carboplatin
Phase: Phase 2
Ages Eligible For Study:
Subjects must be treated at Stanford University Medical Center for the entire length of study participation. 1. Patients with histologically or cytologically confirmed adenocarcinoma of the GEJ or stomach. 2. Patients must be deemed unresectable due to involvement of critical vasculature or adjacent organ invasion. If unresectable, patients must show evidence of disease progression prior to enrollment. 3. Patients with prior surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic disease if there is substantial clinical ambiguity regarding the nature or source of apparent metastases. 4. Prior carboplatin as neoadjuvant or adjuvant therapy will be allowed if >= 6 months from the time of study entry. 5. If patients use aspirin (>325mg/day) or NSAIDS at the time of enrollment, they must have a 10 day washout period prior to beginning protocol treatment. 6. Low molecular weight heparin (or its equivalent, excluding warfarin) will be allowed for treatment of venous thromboembolic events if patients have no evidence of bleeding on full-dose anticoagulation. 7. Patients must have a primary or metastatic lesion measurable in at least one dimension by Modified RECIST criteria (see Section 11.2.3) within 4 weeks prior to entry of study 8. Patients must have ECOG performance status of 0-1 9. Patients must be >= 18 years of age 10. Laboratory values <= 2 weeks prior to randomization: - Absolute Neutrophil Count (ANC) >= 1.5 x 109/L (>= 1500/mm3) - Platelets (PLT) >= 100 x 109/L (>= 100,000/mm3) - Hemoglobin (Hgb) >= 9 g/dL - Serum creatinine <= 1.5 x ULN - Serum bilirubin <= 1.5 x ULN (<= 3.0 x ULN if liver metastases present) - Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) <= 3.0 x ULN (<= 5.0 x ULN if liver metastases present). Note: ERCP or percutaneous stenting may be used to normalize the liver function tests. 11. Life expectancy >= 12 weeks 12. Inclusion and exclusion criteria for DCE-MRI and DWI imaging will be determined by CT scan as part of routine post-chemotherapy imaging. Subjects will be eligible if one liver metastasis is greater than 1 cm in size. Participation in the DCE-MRI and DWI correlate is not required for eligibility. 13. Ability to give written informed consent according to local guidelines