Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC) (NCT00215202) | Clinical Trial Compass
CompletedPhase 2
Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
United States16 participantsStarted 2004-08
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
The primary objective of this study is to measure the objective response rate by RECIST (radiographic) criteria of nonresectable adrenocortical cancer to ZD1839