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A Trial of ZD6474, Paclitaxel, Carboplatin, 5-Fluorouracil, and Radiation Therapy Followed by Surgery

NCT01183559 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-01-22

Study results available
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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

Conditions

  • Cancer of the Esophagus
  • Adenocarcinoma of the Gastroesophageal Junction
  • Cancer of the Stomach

Interventions

DRUG

Vandetanib

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

DRUG

5 Fluorouracil (FU)

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

DRUG

Carboplatin

Carboplatin AUC=5 days 1 and 29 during radiation therapy

DRUG

Paclitaxel

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

RADIATION

External Beam Radiation Therapy (RT)

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Igor Astsaturov,, M.D., Ph.D. · Fox Chase Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-07
Primary Completion
2010-11-30
Completion
2011-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01183559 on ClinicalTrials.gov