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

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: AstraZeneca; Dana-Farber Cancer Institute; Kentuckiana Cancer Institute; M.D. Anderson Cancer Center
• Treatments: Gefitinib

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