Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma (NCT00780494) | Clinical Trial Compass
CompletedPhase 2
Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma
United States35 participantsStarted 2009-02
Plain-language summary
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 90% over historical controls.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with histologically or cytologically confirmed adenocarcinoma of the GEJ or stomach.
✓. 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.
✓. 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.
✓. Prior carboplatin as neoadjuvant or adjuvant therapy will be allowed if \>= 6 months from the time of study entry.
✓. 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.
✓. 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.
✓. 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
✓. Patients must have ECOG performance status of 0-1
3. Ability to give written informed consent according to local guidelines
✕. Disease-Specific Exclusions
✕. Prior chemotherapy for metastatic disease
✕. Prior full field radiotherapy \<= 4 weeks or limited field radiotherapy \<= 2 weeks prior to enrollment. Patients must have recovered from all therapy-related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.
✕. Prior biologic or immunotherapy \<= 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
✕. Prior therapy with anti-VEGF agents
✕. If history of other primary cancer, subject eligible only if she or he has:
✕. Concurrent use of other investigational agents and patients who have received investigational drugs \<= 4 weeks prior to enrollment.