CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 9 enrolled
Drug / intervention
Vandetanib +4 moredrug
Likely dose
Vandetanib 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01183559
NCT01183559Phase 1Completed
CompareCT.gov

Induction Therapy for Locally Advanced, Resectable Cancer of the Esophagus, Gastroesophageal (GE) Junction and Gastric Cancer: A Phase I Trial of ZD6474 (Zactima, Vandetanib), Paclitaxel, Carboplatin, 5-Fluorouracil, and Radiation Therapy Followed by Surgery

Fox Chase Cancer Center·interventional·Posted Aug 17, 2010·Updated Jan 22, 2021

In Brief

A Phase 1 clinical trial evaluating Vandetanib, 5 Fluorouracil (FU), and 3 other interventions for Cancer of the Esophagus and 2 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed Summary

The purpose of the study is to determine the most tolerable and safe dose of ZD6474 (Zactima, Vandetanib) when given with standard chemotherapy, radiation therapy and surgery in patients with cancer of the esophagus

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Cancer of the Stomach
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 1CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 17, 2010
Enrollment StartAug 7, 2008
Primary CompletionNov 1, 2010
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.9 years ago

Interventions

Vandetanibdrug

Vandetanib 100mg orally escalating to doses of 200 mg daily 7 days a week until completion of radiation therapy

5 Fluorouracil (FU)drug

5-FU 225 mg/m2/day continuous infusion over96 hours during radiation therapy

Carboplatindrug

Carboplatin AUC=5 days 1 and 29 during radiation therapy

Paclitaxeldrug

Paclitaxel 50 mg/m2 days 1, 8, 15, 22, 29 during radiation therapy

External Beam Radiation Therapy (RT)radiation

External Beam Radiation Therapy(XRT)to a total dose of 4,500 centiGray (cGy) (180 cGy fractions daily) Monday through Friday for five weeks