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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT00780494
Phase
PHASE2
Status
Completed

Conditions

  • Gastric (Stomach) Cancer
  • Gastrointestinal Stromal Tumor (GIST)
  • Neoplasm of Cardioesophageal Junction
  • Stomach Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    Intravenous 15 mg/kg
  • carboplatin — DRUG
    AUC 6, Intravenously Day 1 every 21 days
  • capecitabine — DRUG
    850mg/m2, Orally twice daily days 1-14 every 21 days.

Study Details

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.

Key Dates

First listed
Oct 27, 2008
Start date
Feb 28, 2009
Status verified
Dec 2024
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: bevacizumab+ carboplatin +capecitabine
    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.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-

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