- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00215202
Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
A Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Kentucky
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Louisville, Kentucky, United States, 40202
- Kentuckiana Cancer Institute PLLC
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana Farber Cancer Institute
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
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Texas
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Houston, Texas, United States, 77030
- The University of Texas M.D. Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary objective of this study is to measure the objective response rate by RECIST (radiographic) criteria of nonresectable adrenocortical cancer to ZD1839
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Secondary Outcome Measures
Outcome Measure |
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Time to progression
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Duration of response
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Duration of survival
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Adverse event profile
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Vivek Samnotra, MD, Dartmouth-Hitchcock Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Adrenal Gland Diseases
- Adrenal Cortex Neoplasms
- Adrenal Gland Neoplasms
- Adrenal Cortex Diseases
- Carcinoma
- Adrenocortical Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Gefitinib
Other Study ID Numbers
- D0327
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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