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A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-Based Therapy

This study has been completed.

Sponsored by: AGO Ovarian Cancer Study Group
Information provided by: AGO Ovarian Cancer Study Group
ClinicalTrials.gov Identifier: NCT00189358
  Purpose

Although initially responsive to cytoreductive surgery and platinum- and/or taxane-based chemotherapy, a majority of patients with epithelial ovarian cancer, cancer of the fallopian tube or the peritoneum will eventually relapse. Recurrence within 6 months after completing platinum-containing chemotherapy indicates a platinum-refractory cancer disease. New therapeutic strategies are required in platinum-refractory disease. Inhibition of growth signals induced by the epidermal growth factor receptor pathway, or by the estrogen receptor pathway provides promising targets in epithelial ovarian cancer, cancer of the fallopian tube or the peritoneum. The trial is to evaluate the safety and tolerability of the combination of the epidermal growth facto tyrosine kinase inhibitor ZD1839 and the clinically established antiestrogen tamoxifen.


Condition Intervention Phase
Ovarian Cancer
Cancer of the Fallopian Tube
Peritoneal Cancer
Drug: ZD1839
Drug: tamoxifen
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

ChemIDplus related topics:   ZD1839    Tamoxifen    Tamoxifen citrate    Tyrosine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-Based Therapy

Further study details as provided by AGO Ovarian Cancer Study Group:

Primary Outcome Measures:
  • Safety and tolerability

Secondary Outcome Measures:
  • objective response rate
  • time to progression
  • overall survival

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

histologically confirmed epithelial ovarian cancer, cancer of the fallopian tube or peritoneum refractory to platinum- and taxane-based chemotherapy measurable or non-measurable disease written informed consent aged 18 years or older Karnofsky performance status > 60%

Exclusion Criteria:

complete bowel obstruction symptomatic brain metastases known hypersensitivity to evaluated drugs inadequate kidney function inadequate hepatic function evidence of clinically active interstitial lung disease history of congestive heart failure > NYHA 2

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189358

Locations
Germany
Dept. of Gynecology, Evangelisches Krankenhaus    
      Duesseldorf, Germany, 40217

Sponsors and Collaborators
AGO Ovarian Cancer Study Group

Investigators
Principal Investigator:     Uwe Wagner, Prof.Dr.     AGO Ovarian Cancer Study Group    
  More Information


Study ID Numbers:   AGO-OVAR 2.6
First Received:   September 12, 2005
Last Updated:   September 12, 2005
ClinicalTrials.gov Identifier:   NCT00189358
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AGO Ovarian Cancer Study Group:
cancer  
cancer alternative therapies  
ovarian cancer  
tyrosine kinase inhibitor  

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Tamoxifen
Fallopian Tube Neoplasms
Carcinoma
Fallopian Tube Diseases
Genital Diseases, Female
Endocrinopathy
Fallopian tube cancer
Taxane
Gefitinib
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Estrogen Antagonists
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Protein Kinase Inhibitors
Pharmacologic Actions
Adnexal Diseases
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on October 10, 2008




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