Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
This study has been completed.
Sponsor:
Dartmouth-Hitchcock Medical Center
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
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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:
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) |
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) |
| 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
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
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 |
| Health Authority: | United States: Institutional Review Board |
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 September 30, 2016