Neoplasms

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Carboplatin

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.

bevacizumab

carboplatin

850mg/m2, Orally twice daily days 1-14 every 21 days.

capecitabine

Pamela Kunz, MD

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.

Primary Objectives:

To investigate if the addition of Bevacizumab to standard chemotherapy for metastatic or unresectable GEJ and gastric adenocarcinoma will improve PFS by 90% over historical controls.

Secondary Objectives:

* Assess toxicities using CTCAE v3.0
* Evaluate overall survival (OS) using Kaplan-Meier analysis
* Evaluate objective response rate (RR) by RECIST criteria
* Explore biomarkers of tumor response: CEA, CA 19.9, and serum VEGF
* Bank serum and tissue for future correlative studies
* Evaluate CT Perfusion to predict early therapeutic response to combination chemotherapy and anti-angiogenic therapy (OPTIONAL).

Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma

A Phase II Study of Capecitabine, Carboplatin, and Bevacizumab for Metastatic or Unresectable Gastroesophageal Junction and Gastric Adenocarcinoma

Tumor progression was assessed according to the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), presented below.

* Complete Response (CR) = Disappearance of all target lesions
* Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions
* Objective Response (OR) = CR + PR
* Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
* Stable disease (SD) = Small changes that do not meet any of the above criteria.

Progression-Free Survival is assessed as the number of evaluable participants who were alive without disease progression at 1 year. Participants without out assessment at 12 months will not be included.

Toxicity was assessed as the number of adverse events ≥ Grade 3 and also possibly, probably, or definitely related to bevacizumab. The outcome is reported as the total number of applicable events, and as the number of events that were a hematologic toxicity; a non-hematologic toxicity; which are numbers without dispersion.

Overall survival (OS) will be assessed from time from the date of enrollment to the date of death due to any cause or the last date the patient was known to be alive (censored observation) at the date of data cutoff for the final analysis. The outcome is presented as the median survival in days with standard deviation.

Tumor response was assessed per the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions, and assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays/radiologic scan. Response was determined based on the criteria below.

* Complete Response (CR) = Disappearance of all target lesions
* Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions
* Objective Response (OR) = CR + PR
* Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
* Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome is provided as the number of participants who achieved each of the defined responses, with objective (overall) response defined as the sum of CR and PR. The outcome is reported as values without dispersion.

The detected blood levels for tumor biomarkers CEA and CA 19.9 were to be correlated to the results for progression-fee survival (PFS), with the outcome presented as the median with standard deviation.

The detected blood levels for tumor biomarker vascular endothelial growth factor (VEGF) were to be correlated to the results for progression-fee survival (PFS), with the outcome presented as the median with standard deviation.

Genentech, Inc.

Pamela L. Kunz

Asst Prof-Med Ctr Line

Bevacizumab+ Carboplatin +Capecitabine

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Pamela Kunz

Those participants who did not receive follow-up at 12 months were considered lost-to-follow-up and not evaluable for progression, and were censored from the analysis.

Progression-Free Survival (PFS)

Total Toxicity Events

Total Hematologic Toxicities

Total Non-hematologic Toxicities

All participants were included in this analysis.

Adverse Events ≥ Grade 3 and Related to Bevacizumab

Data were available for all participants. Participants remaining alive were censored at last date assessed.

Overall Survival (OS)

Partial Response

Complete Response (CR)

Objective Response (OR) = CR + PR

Stable Disease

Progressive Disease

Data for clinical response was not available for all participants. Response data are only reported for participants for whom response is known.

Objective (Overall) Therapeutic Response

Based on the objective results, it was determined that the any results from tumor biomarker analyses would be of little value, and the measurement for tumor biomarkers in the collected samples were not conducted. Accordingly, there is no data to be analyzed.

CEA and CA 19.9 Tumor Response Biomarkers

Studies published during the conduct of this study demonstrated that this assessment was not useful, and the samples were not collected. Accordingly, there is no data to be analyzed.

Spots Global Cancer Trial Database for Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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