Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
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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) |
- The primary objective of this study is to measure the objective response rate by RECIST (radiographic) criteria of nonresectable adrenocortical cancer to ZD1839
- 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00215202
| 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 | |
| Principal Investigator: | Vivek Samnotra, MD | Dartmouth-Hitchcock Medical Center |
More Information
Additional Information:
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 Adenocarcinoma Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Carcinoma |
Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on March 03, 2015