Status:
COMPLETED
Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
AstraZeneca
M.D. Anderson Cancer Center
Conditions:
Nonresectable Adrenocortical Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 Mitot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00215202
Start Date
August 1 2004
End Date
January 1 2007
Last Update
May 17 2018
Active Locations (4)
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1
Kentuckiana Cancer Institute PLLC
Louisville, Kentucky, United States, 40202
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
4
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030