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

Completed · Phase 2

Conditions studied: Nonresectable Adrenocortical Carcinoma

In brief

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).

Key facts

Study ID

NCT00215202

Run by

Dartmouth-Hitchcock Medical Center

People needed

16

Starts

2004-08-01

Expected to finish

2007-01-01

Last updated by the study team

2018-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kentuckiana Cancer Institute PLLC — Louisville, Kentucky, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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