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Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head and Neck Cancer

Intervention: Gefitinib (Drug); Gefitinib (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Christoph Rochlitz, Prof Dr med, Principal Investigator, Affiliation: University Hospital of Basel
Madeleine Billeter, MD, Study Director, Affiliation: AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland
Verena Renggli, Study Chair, Affiliation: AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland

Summary

To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa

Clinical Details

Official title: Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial

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

Primary outcome: To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa

Secondary outcome:

Both cohorts overall survival (OS) local control (LC) rate at six months and at one year

Cohort 1 only time-to-recurrence (TTR)

Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Written informed consent

- Age over 18 years

- Histologically proven squamous cell cancer of the head & neck (SCCHN)

- Indication for postoperative Radiotherapy: pT3, pT4, pN2b, pN2c, pN3

Exclusion Criteria:

- Hypersensitivity to ZD1839 or any of the excipients of this product

- Tumour stage M1

- Co-existing malignancies diagnosed within the last 5 years. Exceptions: basal cell

carcinoma, cervical cancer in situ

- Absolute neutrophil counts <1. 5 x 109

Locations and Contacts

Research Site, Basel, Switzerland

Research Site, Bern, Switzerland

Additional Information

Starting date: February 2004
Last updated: September 21, 2010

Page last updated: August 23, 2015

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