CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Bevacizumab +2 morebiological
Likely dose
Bevacizumab 7.5 mg/kg IV on day 1 of each cycle; Docetaxel 70 mg/m² IV over 60 minutes on day 1 of each cycle; Oxaliplatin 75 mg/m² IV over 120 minutes on day 1 of each cycleAI-extracted
Key inclusion· 6
  • Histologically confirmed gastric or gastroesophageal junction adenocarcinoma
  • Locally advanced unresectable or metastatic disease
  • Measurable disease: ≥1 lesion ≥20 mm by conventional imaging or ≥10 mm by spiral CT
  • Age ≥18 years
Key exclusion· 8
  • CNS or brain metastases
  • Peripheral neuropathy >grade 1
  • History of deep venous thrombosis requiring anticoagulation
  • Active angina, myocardial infarction within past year, or cerebrovascular accident within past year

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00217581
NCT00217581Phase 2Completed

Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer

Barbara Ann Karmanos Cancer Institute·interventional·Posted Sep 22, 2005·Updated Mar 26, 2019

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Docetaxel, and 1 other intervention for Esophageal Cancer and Gastric Cancer. Completed, enrolled 39 participants across 4 sites.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with oxaliplatin and docetaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or metastatic stomach or gastroesophageal junction cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartOct 1, 2004
Primary CompletionNov 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 20.8 years ago

Interventions

Bevacizumabbiological

Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.

Docetaxeldrug

Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;

Oxaliplatindrug

Must be administered 3rd after Bevacizumab and Docetaxel. 75 mg/m(2), IV over 120 minutes, Day 1 of each cycle.