A Phase II Trial of ZD1839 (Iressa®) in Patients with Nonresectable Adrenocortical Carcinoma (ACC)

Primary Investigator: Vivek Samnotra, MD
Clinical Research Administrator: Pam Simmons (EMAIL: p.simmons@fmhospital.com).
Contact: 603-335-8490
Protocol Number: DMS 0327

This study is active and accruing patients. Call 603-335-8490 for details.

Summary:

This clinical trial examines a new treatment for people with advanced Adrenocortical Carcinoma (or Cancer of the Adrenal Gland), using the pill IRESSA® (ZD1839)

Background and Rationale:

Nonresectable Adrenocortical Carcinoma is an extremely rare malignancy. Adrenocortical Carcinoma (ACC) has a very poor prognosis; surgery is the only potential curative option and the treatment of choice for localized disease. Patients with localized primary tumors that are excisable have a 40% chance for cure, however patients with recurrent or metastatic disease are rarely curable by surgery alone.

Current treatment regimes for inoperable Adrenocortical Carcinoma (advanced disease) are combinations of traditional chemotherapy (e.g. Adriamycin, Cisplatinum and Etoposide) and or Mitotane -- a compound related to the insecticide DDT. Most studies report response rates of only 20 -30% with these systemic therapies. Given that there is no cure for inoperable disease and that the above therapies are associated with significant toxicity it is reasonable to try newer agents in the setting of clinical trials to see if a new standard of care can be developed for this disease.

IRESSA® (ZD1839) is of particular interest because many patients with Adrenocortical carcinoma (ACC) have tumors that express EGFR, the epidermal growth factor receptor. The current rate of EGFR expression in this tumor is unknown.

Target subject population:

Adult (18 years of age or older) patients with pathologically confirmed adrenocortical cancer, who are not surgical candidates. Patients who have receiced other medications that target EGFR are inelligible for this study.

Investigational product, dosage and mode of administration

- IRESSA® (ZD1839) 250-mg oral (pill form) daily dose. Each cycle will be 21 days.
- Pharmaceuticals provided free of charge for 10 months to trial enrollees.