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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.
First Received: September 12, 2005   No Changes Posted
Sponsor: 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

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

Resource links provided by NLM:


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

No publications provided

Study ID Numbers: AGO-OVAR 2.6
Study First Received: September 12, 2005
Last Updated: September 12, 2005
ClinicalTrials.gov Identifier: NCT00189358     History of Changes
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

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Bone Density Conservation Agents
Ovarian Diseases
Selective Estrogen Receptor Modulators
Protein Kinase Inhibitors
Genital Diseases, Female
Estrogen Receptor Modulators
Neoplasms by Site
Therapeutic Uses
Gefitinib
Endocrine Gland Neoplasms
Estrogen Antagonists
Ovarian Neoplasms
Antineoplastic Agents, Hormonal
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Tamoxifen
Fallopian Tube Neoplasms
Pharmacologic Actions
Fallopian Tube Diseases
Adnexal Diseases
Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009