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Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
M.D. Anderson Cancer Center
Dana-Farber Cancer Institute
Kentuckiana Cancer Institute
Information provided by:
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00215202
First received: September 15, 2005
Last updated: August 13, 2008
Last verified: August 2008
History of Changes
  Purpose

The use of Iressa will result in a greater than 20% response rate in patients with nonresectable adrenocortical cancer who have previously been treated with one other form of systemic therapy (either Mitotane or chemotherapy).


Condition Intervention Phase
Nonresectable Adrenocortical Carcinoma
 Drug: Iressa (ZD1839)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • The primary objective of this study is to measure the objective response rate by RECIST (radiographic) criteria of nonresectable adrenocortical cancer to ZD1839

Secondary Outcome Measures:
  • Duration of response
  • Adverse event profile
  • Duration of survival
  • Time to progression

Estimated Enrollment: 33
Study Start Date: August 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Adrenocortical carcinoma is a rare cancer with an incidence of 1.5 to 2 per million people in the United States. Surgery is the only potentially curative option. Current systemic therapy, either Mitotane or chemotherapy, typically gives response rates of 20% or less. This study is designed to see if the newer targeted therapy, Iressa, may be of benefit for patients with this fatal disease.

Patients with nonresectable adrenocortical cancer who have progressed on at least one other form of systemic therapy (Mitotane or chemotherapy) will be given Iressa 250 mg by mouth daily until disease progression. This is a standard two-stage Phase II clinical trial. Eighteen patients with measurable disease will be enrolled in the first stage. If there is at least one responder, then an additional nine patients with measurable disease will be enrolled for a total of 27 patients with measurable disease. Up to six patients without measurable disease may be enrolled at any point in this study. Iressa will be provided free for all study participants.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be able to provide informed consent
  • Subject must be 18 years of age or older
  • Subject must have histologically confirmed ACC by Department of Pathology at Dartmouth Hitchcock Medical Center
  • Subject must have inoperable disease
  • Subject must have received some form of systemic therapy prior to enrolling in the study

Exclusion Criteria:

  • known severe hypersensitivity to Iressa
  • other co-existing malignancies diagnosed within the last five years except basal cell cancer or cervical cancer in situ
  • any unresolved CTC grade 2 toxicity from previous anticancer therapy (except alopecia)
  • absolute neutrophil count less than 1.5 x 1,000,000,000 per liter
  • platelets less than 20 x 1,000,000,000 per liter
  • severe uncontrolled systemic disease
  • pregnancy\breastfeeding
  • women who are fertile and not willing to practice abstinence or contraception
  • use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's Wort
  • treatment with a non-approved or investigational drug within 28 days before Day 1 of study treatment
  • prior use of ZD1839 (Iressa) or any other anti-EGFR therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215202

Locations
United States, Kentucky
Kentuckiana Cancer Institute PLLC
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
AstraZeneca
M.D. Anderson Cancer Center
Dana-Farber Cancer Institute
Kentuckiana Cancer Institute
Investigators
Principal Investigator: Vivek Samnotra, MD Dartmouth-Hitchcock Medical Center
  More Information

Additional Information:
click here for more information about this study  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00215202     History of Changes
Other Study ID Numbers: D0327
Study First Received: September 15, 2005
Last Updated: August 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Adrenocortical Cancer
Iressa
Adrenal Cancer

Additional relevant MeSH terms:
Adrenocortical Carcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
 Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013