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A Phase ll Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Metastatic Esophagogastric Adenocarcinomas

Phase 2
18 Years
Open (Enrolling)
Esophageal Neoplasms, Stomach Neoplasms, Neoplasm Metastasis

Thank you

Trial Information

A Phase ll Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Metastatic Esophagogastric Adenocarcinomas

The number of new cases of esophageal and gastric cancers in the United States in 2005 is
14520 for esophageal cancer and 21860 for gastric cancer. Unfortunately, esophageal and
gastric cancers will also account for 13570 and 11550 deaths, respectively, in 2005. The 5
year survival rates for metastatic gastroesophageal, GE junctional, and gastric cancers are
less than 5%. The major current treatment modality for patients with advanced esophageal,
GE junctional, and gastric adenocarcinomas is systemic chemotherapy.

We seek to investigate the efficacy of capecitabine and oxaliplatin in combination with
bevacizumab as first line treatment for metastatic esophagogastric cancers. The choice of
capecitabine and oxaliplatin is made to develop a user-friendly biologically-based regimen,
offering patients oral capecitabine in place of continuous 5FU infusion pumps. Since
capecitabine can be given crushed this regimen may both be active and user-friendly.
Preliminary data in colorectal cancer suggest that the regimen of capecitabine, oxaliplatin,
and bevacizumab has comparable activity to FOLFOX-bevacizumab. The goal of the proposed
regimen is to define a capecitabine and oxaliplatin-based regimen that optimizes biological
approaches over cytotoxic approaches. The addition of bevacizumab to chemotherapy regimens
for metastatic colorectal cancer, metastatic non-small cell lung cancer, and metastatic
breast cancer has shown to improve response rates and overall survival. If active, this
regimen could serve as a first line comparator to the capecitabine, oxaliplatin, and
epirubicin combination. This approach will also help to simplify regimen development across
gastrointestinal cancers.

In addition to the primary efficacy endpoint of this protocol, several correlative endpoints
will also be examined in an exploratory manner. The importance of developing blood-based
and tumor biomarkers has been extensively reviewed. However, the role of such predictive
markers has not been well studied for XELOX-A. This information is important since it may
help define which populations are most likely to benefit and most likely to suffer
significant toxicity from this important GI cancer regimen. This biomarker approach may also
help understand and define mechanisms of sensitivity, resistance, and toxicity that may be
used to guide future hypothesis-driven studies designed to improve the efficacy and safety
of this regimen. The correlative biomarker endpoints include serum, plasma and urine
biomarkers (e.g. VEGF and bFGF), a wound healing model of angiogenesis, and tumor biopsy
studies .


Inclusion Criteria:

- Histologically or cytologically documented and radiographically measurable
adenocarcinoma of the esophagus or stomach that is metastatic/recurrent and not
amenable to potentially curative treatment

- No prior therapy for metastatic disease

- Prior radiation therapy is permitted, provided it is completed > 28 days prior to day
1 of study drug

- Normal organ and marrow function

- Karnofsky Performance Status 70-100%

Primary Exclusion Criteria:

- Unstable or poorly controlled hypertension > 150/100 mm Hg

- Arterial thromboembolic events within 6 months

- Clinically significant uncontrolled cardiac disease

- Significant proteinuria at baseline

- Grade 2 or greater peripheral neuropathy

- History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the progression free survival (PFS) of the combination of bevacizumab, oxaliplatin and capecitabine in patients with previously untreated metastatic esophagogastric adenocarcinoma

Outcome Time Frame:

2+ years from study start date

Safety Issue:


Principal Investigator

Hope E Uronis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:

Pro00008710 (8797)



Start Date:

February 2007

Completion Date:

December 2014

Related Keywords:

  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Neoplasm Metastasis
  • metastatic esophagogastric adenocarcinomas
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Neoplasm Metastasis



Duke University Medical Center Durham, North Carolina  27710
University of Wake Forest Baptist Medical Center Winston Salem, North Carolina  27157-0001