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 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:

Drug Information available for: Gefitinib

Genetic and Rare Diseases Information Center resources: Adrenocortical Carcinoma Adrenal Cancer

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 (Adult, Senior)
Sexes Eligible for Study:	All
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

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: 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


ClinicalTrials.gov Identifier:	NCT00215202 History of Changes
Other Study ID Numbers:	D0327
Study First Received:	September 15, 2005
Last Updated:	August 13, 2008

Keywords provided by Dartmouth-Hitchcock Medical Center:


Adrenocortical Cancer Iressa Adrenal Cancer

Additional relevant MeSH terms:


Carcinoma Adrenocortical 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 Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 16, 2017

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