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Sponsors and Collaborators: |
Stanford University Genentech |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00780494 |
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.
Condition | Intervention | Phase |
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Stomach Cancer |
Drug: bevacizumab Drug: carboplatin Drug: capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Capecitabine, Carboplatin, and Bevacizumab for Metastatic or Unresectable Gastroesophageal Junction and Gastric Adenocarcinoma |
Estimated Enrollment: | 35 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: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:
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
 Exclusion Criteria:a. Disease-Specific Exclusions
1. Prior chemotherapy for metastatic disease 2. 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.
3. Prior biologic or immunotherapy <= 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities 4. Prior therapy with anti-VEGF agents 5. If history of other primary cancer, subject eligible only if she or he has:
Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years 6. Concurrent use of other investigational agents and patients who have received investigational drugs <= 4 weeks prior to enrollment.
7. Hypersensitivity to capecitabine, fluorouracil, or any component of the formulation and or a known deficiency of dihyropyrimidine dehydrogenase.
b. General Medical Exclusions
Acute or chronic liver disease (e.g., hepatitis, cirrhosis) 8. Patients unwilling to or unable to comply with the protocol 9. Life expectancy of less than 12 weeks 10. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study c. Bevacizumab-Specific Exclusions
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | George Albert Fisher M.D. Ph.D. | Stanford University |
Study ID Numbers: | SU-07082008-1238, 98587, GI0002 |
Study First Received: | October 23, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00780494 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Bevacizumab Carboplatin Angiogenesis Inhibitors |
Carcinoma Digestive System Diseases Stomach Diseases Stomach Neoplasms Gastrointestinal Neoplasms Stomach Cancer Adenocarcinoma |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Bevacizumab Carboplatin |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Stomach Diseases Stomach Neoplasms Therapeutic Uses Gastrointestinal Neoplasms Growth Inhibitors Angiogenesis Modulating Agents |