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

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ClinicalTrials.gov Identifier: NCT00215202
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 17, 2018
Sponsor:
Collaborators:
AstraZeneca
M.D. Anderson Cancer Center
Dana-Farber Cancer Institute
Kentuckiana Cancer Institute
Information provided by:
Dartmouth-Hitchcock Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Nonresectable Adrenocortical Carcinoma Drug: Iressa (ZD1839) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
Study Start Date : August 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Duration of response
  2. Adverse event profile
  3. Duration of survival
  4. Time to progression

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215202


Locations
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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
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Principal Investigator: Vivek Samnotra, MD Dartmouth-Hitchcock Medical Center
More Information
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ClinicalTrials.gov Identifier: NCT00215202    
Other Study ID Numbers: D0327
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Keywords provided by Dartmouth-Hitchcock Medical Center:
Adrenocortical Cancer
Iressa
Adrenal Cancer
Additional relevant MeSH terms:
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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