Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

ZD1839 (Iressa™) In Combination With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00247481
First received: November 1, 2005
Last updated: April 22, 2009
Last verified: April 2009
  Purpose

This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial of ZD1839 and placebo in combination with chemotherapy in patients with metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: Gefitinib
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicentre, Randomised, Double-Blind, Non-Comparative Phase II Trial Of ZD1839 (Iressa™) And Placebo In Combination With Chemotherapy With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To estimate the overall response rates (complete response [CR] and partial response [PR]) in the ZD1839-treated group and the placebo-treated group.

Secondary Outcome Measures:
  • o To assess progression-free survival (PFS) in the ZD1839-treated group and the placebo-treated group.
  • o To estimate the duration of response in the ZD1839-treated group and the placebo treated group
  • o To estimate overall survival in the ZD1839-treated group and the placebo-treated group
  • o To estimate time to treatment failure (TTF) in the ZD1839-treated group and the placebo treated group

Estimated Enrollment: 77
Study Start Date: September 2002
Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed breast cancer at a metastatic stage.
  • Uni- or bi-dimensionally measurable lesions (10 mm or 20 mm) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
  • World Health Organisation (WHO) performance status (PS) of 0 to 2
  • Life expectancy of greater than 12 weeks
  • Normal cardiac function (left ventricular ejection fraction [LVEF] by isotopic examination greater than or equal to 55%)

Exclusion Criteria:

  • Symptomatic lepto-meningeal metastasis
  • Concomitant infectious disease
  • Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
  • Incomplete healing from previous oncologic or other surgery
  • Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L
  • Serum creatinine greater than 1.5 times the ULRR or clearance < 60 ml/min
  • ALT or AST greater than 2.5 times the ULRR
  • ALP > 5 times the ULRR
  • ALP > 2.5 times the ULRR and ALT or AST greater than 1.5 times the ULRR
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247481

Locations
France
Research Site
Dijon, France
Research Site
Paris, France
Research Site
Saint Cloud, France
Research Site
Saint Germain en Laye, France
Research Site
Villejuif Cedex, France
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca France Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00247481     History of Changes
Other Study ID Numbers: D7913C00148, 1839IL/0148
Study First Received: November 1, 2005
Last Updated: April 22, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AstraZeneca:
Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014